FDA Registration
Active
🇩🇴 Dominican Republic
Corflex Caribe
Reg #: 3010621943
·
FEI: 3010621943
·
Expires 2026
Products
5
Proprietary Names
673
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Corflex Caribe
- Registration Number
- 3010621943
- FEI Number
- 3010621943
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zona Franca Industrial de San Isidro, antigua nave MFI-2
- City
- Santo Domingo Este
- Country
- DO
Owner / Operator
- Firm Name
- Corflex Global, LLC
- Operator Number
- 1218997
- Address
- 669 EAST INDUSTRIAL, PARK DRIVE
- City
- Manchester
- State
- NH
- Postal Code
- 03109
- Country
- US
US Agent
- Business Name
- Corflex
- Contact Name
- Matthew Grundy
- Address
- 669 E Industrial Park Drive
- City
- Manchester
- State
- NH
- ZIP
- 03109
- Country
- US
- [email protected]
- Phone
- 603 6233344 ext. 179
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2013-02-13 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2001-10-12 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2013-12-16 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2013-12-16 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2001-10-12 |
Proprietary Names
CRYOTHERM GEL POUCH ONLY 5.75" x 11.5"
CRYOTHERM POUCH W/GEL 5.75" x 11.5"
NYLON GEL POUCH ONLY 5.75" x 11.5"
UNIVERSAL COMFORT SHOULDER IMMOBILIZER
ULTRA SHOULDER IMMOBILIZER W/PAD M
ULTRA ARM SLING W/PAD XS
BLACK TRICOT ARM SLING M
BLACK TRICOT SHOULDER IMMOBILIZER XL
1.5" X 2" LOW PROFILE HOOK TAB W DEADENED TIP
ULTRA SHOULDER ABDUCTION PILLOW W/SLING L
BLACK ELASTIC W/1" HOOK 1.5 X 6.5"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 18"
ULTRA ARM SLING W/PAD XL
HOOK 65 TONGUE BLACK 1.5" X 2.5"
RANGER SLING STRAP KIT
ULTRA SHOULDER IMMOBILIZER W/PAD XL
BLACK TRICOT ARM SLING XS
STRAP WHITE #255708 1 X 8.5"
STRAP BLK 2 X 22" (NO LOOP LOC)
FACE STRAP WHITE 1.5 X 7" (9.5" overall length)
ULTRA SHOULDER IMMOBILIZER XS
BLACK TRICOT ARM SLING L
ECONOMIZER ARM SLING S
DALC 9" COOLTEX WRIST SPLINT W/ STRAP IFU
ECONOMIZER SHOULDER IMMOBILIZER M
SHOULDER ABD PILLOW W/FIRM FIT SLING L
ECONOMIZER ARM SLING XL
BLACK TRICOT SHOULDER IMMOBILIZER L
ULTRA SHOULDER IMMOBILIZER W/PAD L
RANGER GS SHOULDER ABDUCTION BRACE
WHEATON STRAP 12"
RANGER II COMFORT HARNESS W/PADS
RANGER GS FRAME COVER W/PADDED WAISTBAND
CONTENDER POST-OP ELBOW REPLACEMENT SLING UNIV
RANGER SHOULDER IMMOBILIZER
STRAP WHITE #255701 2 X 15"
BLACK TRICOT ARM SLING S
WHEATON STRAP 08"
BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 8"
RANGER II SHOULDER ABDUCTION PILLOW W/SLING
ELASTIC SHOULDER IMMOBILIZER S
FIRM FIT SHOULDER ABDUCTION PILLOW
SPACER MESH BLACK 100 58" WIDTH
ECONOMIZER SHOULDER IMMOBILIZER XL
STRAP BLACK 1"X8.5"
RANGER PILLOW
ULTRA SHOULDER IMMOBILIZER XL
STRAP ELASTIC BLACK 3"X12"
ULTRA SHOULDER ABD PILLOW SM/MED
STRAP ELASTIC BLACK 3"X8"
TEMP MATERIAL SUBSTITUTION NOTE 2.125" X 5.5"
ELASTIC SHOULDER IMMOBILIZER XL
ACETAL D-RING BLACK 1.5"
FACE STRAP WHITE 1.5 X 9" (11.5" overall length)
RANGER SHOULDER SLING BODY
ULTRA ARM SLING 2XL
ULTRA ARM SLING S
3" x 14.5" PERF ELASTIC STRAP MD-L
ULTRA SHOULDER IMMOBILIZER M
ECONOMIZER ARM SLING XS
ELASTIC SHOULDER IMMOBILIZER XS
PADDED STRAP SLING XL
STRAP BLK 2 X 15" (NO LOOP LOC)
RANGER AP FRAME PAD
FACE STRAP BLACK 1.5 X 8" (10.5" overall)
61MM BLK POLYURENTHANE BALL W/LOGO
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 20"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 24"
RANGER SHOULDER SLING
PADDED STRAP SLING XS
PALMAR STAY 2 BEND 1" X 6.75"
FACE STRAP WHITE 1.5 X 10.5" (12.5" overall length)
SLING PADDED STRAP BLUE FOAM W/HOOK 40"
PADDED STRAP SHOULDER IMMOBILIZER XL
ULTRA ARM SLING W/PAD M
3" x 12.5" PERF ELASTIC STRAP XS-SM
STRAP POLYCAST WHITE 1 X 9"
STRAP ANGLE CUT BLACK 1"X9"
BLACK ELASTIC W/1" HOOK 1.5 X 5.5"
CORFLEX LACE ALIGN TLSO PANEL HOOD & COVER FABRIC ONLY
ECONOMIZER SHOULDER IMMOBILIZER S
SHOULDER ABD PILLOW W/FIRM FIT SLING M
ULTRA ARM SLING XS
ELASTIC SHOULDER IMMOBILIZER L
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 14"
ULTRA SHOULDER IMMOBILIZER W/PAD S
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 28"
ECONOMIZER ARM SLING 2XS
STRAP WHITE #255706 2 X 22" (25" overall)
RANGER SLING CUFF DIE CUT BODY
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 22"
STRAP W/LOOP-LOC & VEL-LOOP 1"X16"
WHEATON STRAP 10"
BLACK TRICOT SHOULDER IMMOBILIZER M
3" x 16.5" PERF ELASTIC STRAP 3XL
ELASTIC SHOULDER IMMOBILIZER 2XL
SHOULDER ABD PILLOW BALL HOLDER W/BALL
FACE STRAP BLACK 1.5"X10"
HOOK TONGUE BLACK 2 X 3"
PADDED STRAP SHOULDER IMMOBILIZER XS
BLACK TRICOT ARM SLING XL
ULTRA SHOULDER IMMOBILIZER S
STRAP BLACK 2 X 18"
STRAP BLACK 2 X 26"
HOOK 88 TONGUE BLACK 1.5" X 2.5"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 16"
WAIST PADDED STRAP BLUE FOAM W/HOOKS 33"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 34"
HOOK ALLIGATOR TAB W/KNIT LOOP 1" X 1.25"
STRAP W/LOOP-LOC & VEL-LOOP 1"X27"
STRAIGHT STAY 1/2" X 6"
LOOP 1.5"X1" WITH 1.5" LOOP LOC - BLACK
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 30"
3MM AIRMESH NS BLK 59/60"
STRAP W/LOOP-LOC & VEL-LOOP 1"X29"
ECONOMIZER SHOULDER IMMOBILIZER L
STRAP ELASTIC BLACK 3"X10"
SUPPLY CHAIN MISC ORDERS
BLACK MOLDED HOOK TAB W/KNIT LOOP 1.25"x2.5"
STRAP W/LOOP-LOC & VEL-LOOP 1"X23"
PADDED STRAP SLING UNIVERSAL
RANGER GS SPLINT FRAME W/COVER
BLACK ELASTIC W/1" HOOK 1.5 X 5"
ULTRA SHOULDER IMMOBILIZER L
FACE STRAP BLACK 1.5 X 9" (11.5" overall)
ULTRA SHOULDER ABDUCTION PILLOW W/SLING M
PADDED STRAP SHOULDER IMMOBILIZER UNIVERSAL
ELASTIC SHOULDER IMMOBILIZER 3XL
ULTRA ARM SLING M
STRAP BLACK 2"X14.5"
STRAP BLACK 2 X 34"
STRAP W/LOOP-LOC & VEL-LOOP 1"X18"
RANGER UNIVERSAL SLING
LDPE 1/8" X 24" X 24" WHITE
STRAP BLACK 2 X 28"
ULTRA ARM SLING L
RANGER SHOULDER ABDUCTION PILLOW WITH SLING
ULTRA ARM SLING XL
RANGER GS SHOULDER ABD BRACE IFU (23-2360)
8" COOLTEX THUMB SPICA W/ STRAP IFU
STRAP ANGLE CUT BLACK 1.5"X10"
LOOP 1"X1" WITH 1" LOOP LOC - BLACK
2" X 2" LOW PROFILE HOOK TAB W DEADENED TIP
ULTRA ARM SLING W/PAD S
COLLAR & CUFF SLING
STRAP BLACK 2 X 22"
ULTRA SHOULDER IMMOBILIZER 2XS
ULTRA SHOULDER IMMOBILIZER W/PAD XS
FACE STRAP WHITE 1.5 X 8" (10.5" overall length)
BLACK TRICOT SHOULDER IMMOBILIZER XS
POEB HOOK BLACK METAL CUFF 3" X 1.5"
SHOULDER ABD PILLOW W/FIRM FIT SLING XL
ELASTIC SHOULDER IMMOBILIZER M
HOOK BEL-TIP W/KNIT LOOP BLACK 2 X 2"
ULTRA ARM SLING W/PAD L
ER SHOULDER WEDGE AND STRAP
3" x 15.5" PERF ELASTIC STRAP XL-2XL
RANGER II GS SHOULDER ABD BRACE IFU (23-2560)
EZ TAB BLACK 2 X 4"
ULTRA SHOULDER ABDUCTION PILLOW W/SLING S
STRAP WHITE 2" X 12 1/2"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 36"
UNIVERSAL SLING & SWATHE
SHOULDER ABD PILLOW W/FIRM FIT SLING S
BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 5.5"
STRAP BLK 2 X 24"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 32"
ECONOMIZER ARM SLING L
BLACK ALLIGATOR TAB W/KNIT LOOP 1.25"x3"
EXTENDED + MID LENGTH HUMERAL STRAP
STRAP BLACK 2 X 20"
ULTRA SHOULDER ABDUCTION PILLOW W/SLING XL
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 26"
ULTRA SHOULDER ABD PILLOW LG/ X-LG
PALMAR STAY 2 BEND 1" X 7.5"
STRAP W/LOOP-LOC & VEL-LOOP 1"X25"
RANGER SLING AND SHOULDER IMM IFU (21-1960/23-1960)
LEO G. STEIN LOOP DOUBLE FACED (3610) BLK 1.5"
ECONOMIZER ARM SLING M
STRAP W/LOOP-LOC & VEL-LOOP 1"X21"
BLACK TRICOT SHOULDER IMMOBILIZER S
STRAP BLACK 2 X 30"
CKI / WHEATON STRAP 10"
CKI / WHEATON STRAP 8"
CKI/ WHEATON STRAP 12"
CKI STRAP 10"
CKI STRAP 12"
PANEL ELASTIC ABDOMINAL BINDER 12" 2XL
PANEL ELASTIC ABDOMINAL BINDER 9" XL
UNIVERSAL ABDOMINAL BINDER 12"
CRISS CROSS TACKING
UNIVERSAL ABDOMINAL BINDER 9"
PANEL ELASTIC ABDOMINAL BINDER 12" M
PANEL ELASTIC ABDOMINAL BINDER 12" XL
PANEL ELASTIC ABDOMINAL BINDER 9" S
PANEL ELASTIC ABDOMINAL BINDER 9" M
PANEL ELASTIC ABDOMINAL BINDER 9" L
PANEL ELASTIC ABDOMINAL BINDER 9" 4XL
PANEL ELASTIC ABDOMINAL BINDER 12" L
PANEL ELASTIC ABDOMINAL BINDER 9" 2XL
PANEL ELASTIC ABDOMINAL BINDER 12" 4XL
PANEL ELASTIC ABDOMINAL BINDER 12" 3XL
PANEL ELASTIC ABDOMINAL BINDER 9" 3XL
PANEL ELASTIC ABDOMINAL BINDER 12" S
COOLTEX 13" KNEE SL OP POP W/HINGE 4XL
COOLTEX 13" ANT CL KNEE WRAP W/HINGE 2XL
20" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
COOLTEX 6" KNEE-O-TRAKKER W/HINGE 4XL
ULTRA CERVICAL COLLAR 3 1/2" XL
22" UNIVERSAL KNEE IMMOBILIZER X-WIDE HD STAYS
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP 3XL
COOLTEX 13" ANT CL W/ROM HINGE M
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES 4XL
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE S
ULTRA CLAVICLE STRAP 2XL
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XL
SHELL 5 DEGREE PLANTAR "ANY SIZE BLANK"
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG M
ANKLE WRAP S/M
18" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
KNEE-O-BAND 2XL
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN 4XL
20" UNIVERSAL KNEE IMMOBILIZER X-WIDE HD STAYS
S/M VENTRAL LINER
COOLTEX 13" ANT CL W/ROM HINGE OP POP S
MARATHON ACTIVE LACE-UP ANKLE 3XL
9" COOLTEX WRIST SPLINT W/STRAP XS RT
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE XL
8" SIGNATURE VINYL WRIST SPLINT XL LF
KNEE-O-BAND XL
10" SIGNATURE VINYL WRIST SPLINT S RT
KNEE WRAP UNIV W/STAYS 1/8"
KNEE-O-BAND XS
10" SIGNATURE VINYL WRIST SPLINT M RT
PADDED ELBOW WRAP UNIV
PADDED 90 DEG BLACK PF SPLINT L
ULTRA CLAVICLE STRAP S
COOLTEX 6" KNEE-O-TRAKKER W/HINGE M
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES XL
13" KNEE-O-TRAKKER W/HINGE XS
13" HINGED KNEE SLEEVE OP POP 3/16" M
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG L
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN XL
13" KNEE-O-TRAKKER W/HINGE 3XL
8" ULTRA FIT WRIST SPLINT W/ABD THUMB M LF
10" ULTRA FIT WRIST SPLINT L LF
TENNIS ELBOW SLEEVE W/PAD 1/8" L
20" COMPRESSION KNEE IMMOBILIZER
COOLTEX 6" KNEE-O-TRAKKER XL
ULTRA CERVICAL COLLAR 4 1/2" L
8" SIGNATURE VINYL WRIST SPLINT XL RT
ULTRA CLAVICLE STRAP 2XS
COOLTEX 13" KNEE SL OP POP W/HINGE 2XL
MARATHON SPEED LACE-UP ANKLE XS
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT M
UNIV ELBOW IMMOBILIZER L/XL
6" KNEE-O-TRAKKER M
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES 3XL
12" COMPRESSION KNEE IMMOBILIZER
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB L RT
24" COMPRESSION KNEE IMMOBILIZER
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" 2XL
MARATHON ACTIVE LACE-UP ANKLE XL
10" SIGNATURE VINYL WRIST SPLINT XL LF
6" KNEE-O-TRAKKER W/HINGE S
13" KNEE-O-TRAKKER W/STAYS 3XL
8" COOLTEX THUMB SPICA W/STRAP XL RT
8" SUEDE WRIST LACER SPLINT W/ABD THUMB L RT
8" SIGNATURE VINYL WRIST SPLINT M RT
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" 4XL
9" COOLTEX WRIST SPLINT W/STRAP M LF
8" COOLTEX THUMB SPICA W/STRAP M RT
8" SIGNATURE VINYL WRIST SPLINT L RT
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN 4XL
KNEE WRAP UNIV HINGED 1/8"
M/LG VENTRAL LINER
18" COMPRESSION KNEE IMMOBILIZER
6" KNEE-O-TRAKKER W/HINGE M
8" ULTRA FIT WRIST SPLINT XS LF
13" ANT CL W/ROM HINGE OP POP 3/16" S
10" SIGNATURE VINYL WRIST SPLINT M LF
8" ULTRA FIT COOL WRIST SPLINT XL LF
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB M LF
8" ULTRA FIT WRIST SPLINT W/ABD THUMB L RT
13" KNEE-O-TRAKKER W/HINGE M
ULTRA CERVICAL COLLAR 3 1/2" L
WHEATON KNEE IMMOBILIZER II 18" YOUTH
CRYOTHERM SHOULDER WRAP W/0 GEL
8" SUEDE WRIST LACER SPLINT S RT
16" COMPRESSION KNEE IMMOBILIZER
13" KNEE-O-TRAKKER W/STAYS L
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN 3XL
13" HINGED KNEE SLEEVE OP POP 3/16" S
14" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
10" SIGNATURE VINYL WRIST SPLINT S LF
8" ULTRA FIT WRIST SPLINT M RT
8" COOLTEX THUMB SPICA W/STRAP S RT
ULTRA CLAVICLE STRAP XL
9" COMPRESSION KNEE IMMOBILIZER
ULTRA CERVICAL COLLAR 2" 2XS
8" COOLTEX THUMB SPICA W/STRAP S LF
9" COOLTEX WRIST SPLINT W/STRAP 2XL LF
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG S
COOLTEX 13" KNEE SL OP POP W/HINGE XS
8" ULTRA FIT WRIST SPLINT L RT
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" M
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN S
COOLTEX 13" KNEE SL OP POP W/HINGE L
COOLTEX 13" ANT CL W/ROM HINGE OP POP M
6" KNEE-O-TRAKKER S
POEB HOOK ALLIGATOR TAB 1.25"X2.95"
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE 3XL
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP XL
8" SUEDE WRIST LACER SPLINT W/ABD THUMB L LF
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" XL
6" UNIVERSAL KNEE IMMOBILIZER
COOLTEX 13" ANT CL W/ROM HINGE S
SHOULDER ABDUCTION PILLOW W/SLING XL
8" ULTRA FIT WRIST SPLINT XL LF
13" KNEE SLEEVE 3/16" S
FLEXLOK CONDYLE PAD
ULTRA CERVICAL COLLAR 4 1/2" S
HOOK ALLIGATOR TAB (V2) 1.5"X3"
24" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 2XL
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP M
9" COOLTEX WRIST SPLINT W/STRAP XL RT
MARATHON ACTIVE LACE-UP ANKLE XS
13" ANT CL KNEE WRAP W/HINGE 3/16" 2XL
COOLTEX 6" KNEE-O-TRAKKER 2XL
VQ TLSO ASCENT UNIV
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB XS LF
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB XL RT
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN XS
8" COOLTEX THUMB SPICA W/STRAP M LF
8" ULTRA FIT WRIST SPLINT W/ABD THUMB S RT
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP L
SHOULDER ABDUCTION PILLOW W/SLING S
13" KNEE-O-TRAKKER W/HINGE XL
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN M
PADDED 90 DEG BLACK PF SPLINT S
13" ANT CL KNEE WRAP W/HINGE 3/16" S
8" ULTRA FIT COOL WRIST SPLINT S RT
SHELL "INNER" EXT LENGTH HUMERAL SPLINT "ANY SIZE BLANK"
24" UNIVERSAL KNEE IMMOBILIZER
MARATHON ACTIVE LACE-UP ANKLE 2XL
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP 2XL
5" SIGNATURE VINYL WRIST SPLINT XS RT
MARATHON ACTIVE LACE-UP ANKLE 2XS
CRYOTHERM KNEE WRAP W/0 GEL
ULTRA CERVICAL COLLAR 2" XS
8" COOLTEX THUMB SPICA W/STRAP 2XL LF
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN L
ULTRA CERVICAL COLLAR 2 1/2" M
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP S
13" KNEE-O-TRAKKER W/STAYS XS
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB XL LF
8" ULTRA FIT COOL WRIST SPLINT M LF
8" SUEDE WRIST LACER SPLINT M RT
SHELL 5 DEGREE PADDED PLANTAR SMALL
ULTRA CLAVICLE STRAP XS
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES L
ULTRA CERVICAL COLLAR 3 1/2" UNIV
COOLTEX 6" KNEE-O-TRAKKER L
KNEE-O-BAND M
KNEE-O-BAND L
13" ANT CL W/ROM HINGE OP POP 3/16" M
13" KNEE SLEEVE OP PAT 3/16" S
18" UNIVERSAL KNEE IMMOBILIZER X-WIDE HD STAYS
WHEATON KNEE IMMOBILIZER II 6" INFANT
MARATHON SPEED LACE-UP ANKLE L
13" HINGED KNEE SLEEVE OP POP 3/16" XS
ULTRA XR CUBITAL TUNNEL LINER L/XL
ULTRA CERVICAL COLLAR 3 1/2" S
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB S RT
KNEE-O-BAND S
8" ULTRA FIT WRIST SPLINT W/ABD THUMB XS RT
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" 4XL
8" ULTRA FIT WRIST SPLINT W/ABD THUMB M RT
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" XS
13" KNEE SLEEVE 3/16" 2XL
UNIV ELBOW IMMOBILIZER S/M
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT 3XL
16" UNIVERSAL KNEE IMMOBILIZER
KNEE-O-BAND 3XS
12" UNIVERSAL KNEE IMMOBILIZER
PADDED 90 DEG BLACK PF SPLINT XL
5" SIGNATURE VINYL WRIST SPLINT XS LF
COOLTEX 13" ANT CL W/ROM HINGE L
WHEATON KNEE IMMOBILIZER II 22" ADULT
SHOULDER ABDUCTION PILLOW W/SLING M
8" SUEDE WRIST LACER SPLINT L LF
10" SIGNATURE VINYL WRIST SPLINT L RT
COOLTEX 13" KNEE SL OP POP W/HINGE S
10" ULTRA FIT WRIST SPLINT S LF
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE XS
COOLTEX 13" KNEE SL OP POP W/HINGE M
COOLTEX 6" KNEE-O-TRAKKER XS
18" UNIVERSAL KNEE IMMOBILIZER
COOLTEX 13" ANT CL W/ROM HINGE 4XL
ORTHO SPORT & SPINE REALIGN SPINAL ORTHOSIS LSO PLUS UNIV
10" SIGNATURE VINYL WRIST SPLINT L LF
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB S LF
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT XL
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP 4XL
10" ULTRA FIT WRIST SPLINT UNIV LF
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 2XL
ULTRA CERVICAL COLLAR 2 1/2" S
9" COOLTEX WRIST SPLINT W/STRAP 2XL RT
8" SUEDE WRIST LACER SPLINT W/ABD THUMB XL LF
8" COOLTEX THUMB SPICA W/STRAP XS RT
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 3XL
COOLTEX 13" ANT CL W/ROM HINGE OP POP XL
13" ANT CL W/ROM HINGE OP POP 3/16" XL
MARATHON SPEED LACE-UP ANKLE 2XS
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 4XL
22" UNIVERSAL KNEE IMMOBILIZER
CONTOURED TENNIS ELBOW WRAP UNIV
13" KNEE-O-TRAKKER W/HINGE L
13" KNEE SLEEVE 3/16" 3XL
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" 3XL
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN 2XL
6" KNEE-O-TRAKKER W/HINGE L
9" COOLTEX WRIST SPLINT W/STRAP S LF
COOLTEX 6" KNEE-O-TRAKKER W/HINGE XL
COOLTEX 6" KNEE-O-TRAKKER W/HINGE 3XL
ULTRA CERVICAL COLLAR 2 1/2" XL
13" ANT CL KNEE WRAP W/HINGE 3/16" XL
13" KNEE SLEEVE OP PAT 3/16" M
14" COMPRESSION KNEE IMMOBILIZER
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB XS RT
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG M
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG L
8" SIGNATURE VINYL WRIST SPLINT S RT
13" ANT CL KNEE WRAP W/HINGE 3/16" L
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG XS
SHOULDER ABDUCTION PILLOW W/SLING L
HOOK ALLIGATOR TAB (V2) 1"X2.75"
ULTRA XR CUBITAL TUNNEL LINER S/M
8" SUEDE WRIST LACER SPLINT W/ABD THUMB XS LF
8" ULTRA FIT WRIST SPLINT UNIV LF
8" SUEDE WRIST LACER SPLINT W/ABD THUMB M LF
COOLTEX 13" ANT CL KNEE WRAP W/HINGE S
COOLTEX 13" ANT CL W/ROM HINGE XL
SHELL 5 DEGREE PADDED PLANTAR LARGE
10" ULTRA FIT WRIST SPLINT S RT
COOLTEX 6" KNEE-O-TRAKKER 4XL
13" KNEE-O-TRAKKER W/STAYS 2XL
8" SUEDE WRIST LACER SPLINT XL RT
ULTRA CERVICAL COLLAR 4 1/2" M
WHEATON KNEE IMMOBILIZER II 24" ADULT
6" KNEE-O-TRAKKER W/HINGE XL
ULTRA CLAVICLE STRAP M
10" ULTRA FIT WRIST SPLINT M RT
NATURAL POLYESTER WEB 2 SIDED PRINT ONE COLOR 3/8" X 3.75"
MARATHON SPEED LACE-UP ANKLE S
10.5" COMPRESSION KNEE IMMOBILIZER
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT L
UNIVERSAL PF SUPPORT S/M 10/PK
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE 4XL
RANGER II GS SHOULDER ABDUCTION BRACE
8" ULTRA FIT COOL WRIST SPLINT M RT
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" S
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG XL
13" KNEE SLEEVE 3/16" 4XL
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" L
WHEATON KNEE IMMOBILIZER II 14" CHILD
10" ULTRA FIT WRIST SPLINT UNIV RT
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG 3XL
13" HINGED KNEE SLEEVE OP POP 3/16" L
UNIVERSAL LACER WRIST ORTHOSIS RIGHT
HINGE COVER & EXTENSION STRAP SET
13" KNEE SLEEVE OP PAT 3/16" 4XL
8" SUEDE WRIST LACER SPLINT W/ABD THUMB XL RT
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG 4XL
WHEATON KNEE IMMOBILIZER II 20" ADULT
8" ULTRA FIT WRIST SPLINT W/ABD THUMB S LF
13" KNEE-O-TRAKKER W/STAYS XL
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" M
13" KNEE SLEEVE OP PAT 3/16" 2XL
MARATHON ACTIVE LACE-UP ANKLE M
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 4XL
22" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
8" ULTRA FIT WRIST SPLINT S RT
13" ANT CL W/ROM HINGE OP POP 3/16" 3XL
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XS
13" ANT CL KNEE WRAP W/HINGE 3/16" 4XL
13" HINGED KNEE SLEEVE OP POP 3/16" 3XL
COOLTEX 6" KNEE-O-TRAKKER M
ULTRA CERVICAL COLLAR 4 1/2" XL
10" ULTRA FIT WRIST SPLINT XL LF
8" SUEDE WRIST LACER SPLINT W/ABD THUMB S LF
TENNIS ELBOW SLEEVE W/PAD 1/8" 2XL
MARATHON SPEED LACE-UP ANKLE 3XL
MARATHON SPEED LACE-UP ANKLE XL
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG XS
UNIVERSAL LACER WRIST ORTHOSIS LEFT
8" SUEDE WRIST LACER SPLINT W/ABD THUMB XS RT
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN 3XL
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT S
8" SUEDE WRIST LACER SPLINT L RT
KNEE-O-BAND 2XS
ANKLE WRAP L/XL
ULTRA CERVICAL COLLAR 2 1/2" L
13" HINGED KNEE SLEEVE OP POP 3/16" 4XL
8" SUEDE WRIST LACER SPLINT W/ABD THUMB S RT
COOLTEX 6" KNEE-O-TRAKKER W/HINGE XS
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG 2XL
8" ULTRA FIT WRIST SPLINT W/ABD THUMB XL LF
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG 3XL
8" COOLTEX THUMB SPICA W/STRAP 2XL RT
WHEATON KNEE IMMOBILIZER II 16" ADOLESCENT
13" KNEE SLEEVE OP PAT 3/16" XL
NATURAL POLYESTER WEB 2 SIDED PRINT ONE COLOR 3/8" X 10.5"
13" KNEE SLEEVE 3/16" L
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" 2XL
9" COOLTEX WRIST SPLINT W/STRAP XS LF
8" ULTRA FIT COOL WRIST SPLINT XS RT
TENNIS ELBOW STRAP W/PAD 1/8" UNIV
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" L
13" KNEE SLEEVE OP PAT 3/16" L
COOLTEX 13" PAT STAB W/COR-TRAK BUTTRESS CLOSED POP XS
13" KNEE-O-TRAKKER W/HINGE S
10" ULTRA FIT WRIST SPLINT XS RT
20" UNIVERSAL KNEE IMMOBILIZER
13" KNEE SLEEVE OP PAT 3/16" 3XL
SHELL 5 DEGREE PADDED PLANTAR MEDIUM
UNIVERSAL LACER WRIST ORTHOSIS W/ABDUCTED THUMB LEFT
13" ANT CL W/ROM HINGE OP POP 3/16" 2XL
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN 2XL
ROM HINGE COVER & EXTENSION STRAP SET
COOLTEX 6" KNEE-O-TRAKKER W/HINGE L
8" COOLTEX THUMB SPICA W/STRAP L LF
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT 4XL
6" KNEE-O-TRAKKER W/HINGE XS
13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" 3XL
MARATHON ACTIVE LACE-UP ANKLE S
COOLTEX 6" KNEE-O-TRAKKER S
8" SIGNATURE VINYL WRIST SPLINT S LF
13" KNEE-O-TRAKKER W/STAYS M
8" ULTRA FIT COOL WRIST SPLINT L LF
26" UNIVERSAL KNEE IMMOBILIZER
COOLTEX 6" KNEE-O-TRAKKER W/HINGE S
TENNIS ELBOW SLEEVE W/PAD 1/8" S
8" COOLTEX THUMB SPICA W/STRAP XL LF
8" SUEDE WRIST LACER SPLINT S LF
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE 2XL
6" KNEE-O-TRAKKER 3XL
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE M
5" SIGNATURE VINYL WRIST SPLINT 2XS RT
6" KNEE-O-TRAKKER L
14" UNIVERSAL KNEE IMMOBILIZER
6" KNEE-O-TRAKKER 4XL
8" ULTRA FIT WRIST SPLINT XL RT
8" SIGNATURE VINYL WRIST SPLINT L LF
8" COOLTEX THUMB SPICA W/STRAP L RT
13" KNEE SLEEVE 3/16" M
MARATHON TABS TACK
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG L
8" ULTRA FIT WRIST SPLINT M LF
13" ANT CL W/ROM HINGE OP POP 3/16" L
8" COOLTEX THUMB SPICA W/STRAP XS LF
13" KNEE-O-TRAKKER W/STAYS 4XL
10" ULTRA FIT WRIST SPLINT XS LF
8" ULTRA FIT WRIST SPLINT XS RT
6" KNEE-O-TRAKKER W/HINGE 4XL
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES 2XL
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT 2XL
WHEATON KNEE IMMOBILIZER II 12" YOUNG CHILD
10" ULTRA FIT WRIST SPLINT M LF
8" ULTRA FIT COOL WRIST SPLINT L RT
COOLTEX 13" ANT CL W/ROM HINGE OP POP 2XL
COOLTEX 6" KNEE-O-TRAKKER W/HINGE 2XL
8" ULTRA FIT WRIST SPLINT W/ABD THUMB XS LF
13" HINGED KNEE SLEEVE OP POP 3/16" XL
13" KNEE-O-TRAKKER W/STAYS S
UNIVERSAL PF SUPPORT L/XL 10/PK
8" ULTRA FIT WRIST SPLINT L LF
9" UNIVERSAL KNEE IMMOBILIZER
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES M
8" SUEDE WRIST LACER SPLINT XS RT
CRYOTHERM HIP WRAP W/0 GEL
24" UNIVERSAL KNEE IMMOBILIZER X-WIDE HD STAYS
UNIVERSAL PF SUPPORT S/M
COOLTEX 13" ANT CL W/ROM HINGE 2XL
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN XL
13" ANT CL W/ROM HINGE OP POP 3/16" 4XL
13" PAT STAB COR-TRAK BUTT OP POP W/HINGE 3/16" S
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG S
COOLTEX 13" ANT CL KNEE WRAP W/HINGE XL
TENNIS ELBOW SLEEVE W/PAD 1/8" M
COOLTEX AG 13" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG XL
8" ULTRA FIT COOL WRIST SPLINT XL RT
WHEATON KNEE IMMOBILIZER II 9" TODDLER
9" COOLTEX WRIST SPLINT W/STRAP S RT
SHELL "OUTER" EXT LENGTH HUMERAL SPLINT "ANY SIZE BLANK"
MARATHON ACTIVE LACE-UP ANKLE L
COOLTEX 13" ANT CL KNEE WRAP W/HINGE L
COOLTEX 13" ANT CL W/ROM HINGE 3XL
COOLTEX 13" ANT CL W/ROM HINGE OP POP 4XL
ULTRA CERVICAL COLLAR 4 1/2" UNIV
8" SUEDE WRIST LACER SPLINT M LF
8" ULTRA FIT COOL WRIST SPLINT XS LF
COOLTEX 13" ANT CL KNEE WRAP W/HINGE 3XL
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG M
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN M
ULTRA CERVICAL COLLAR 2 1/2" UNIV
6" KNEE-O-TRAKKER W/HINGE 2XL
COOLTEX 13" ANT CL KNEE WRAP W/HINGE 4XL
HOOK ALLIGATOR TAB (V2) 2"X3.5"
POEB HOOK ALLIGATOR TAB 1.5"X2.95"
13" HINGED KNEE SLEEVE OP POP 3/16" 2XL
10" SIGNATURE VINYL WRIST SPLINT XL RT
8" SUEDE WRIST LACER SPLINT XL LF
8" ULTRA FIT WRIST SPLINT UNIV RT
6" KNEE-O-TRAKKER XL
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB L LF
PADDED 90 DEG BLACK PF SPLINT M
COOLTEX AG 16" HYBRID ANT CLOSURE KNEE OP POP W/ROM HNG S
8" SIGNATURE VINYL WRIST SPLINT M LF
5" SIGNATURE VINYL WRIST SPLINT 2XS LF
UNIVERSAL PF SUPPORT L/XL
COOLTEX 13" ANT CL KNEE WRAP OP POP W/HINGE L
HOOK BEL-TIP W/KNIT LOOP BLACK 1" X 3"
8" SUEDE WRIST LACER SPLINT XS LF
8" ULTRA FIT WRIST SPLINT W/ABD THUMB XL RT
COOLTEX 13" ANT CL W/ROM HINGE OP POP L
22" COMPRESSION KNEE IMMOBILIZER
ULTRA XR CUBITAL TUNNEL LINER M/L
8" ULTRA FIT WRIST SPLINT W/ABD THUMB L LF
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES S
13" KNEE-O-TRAKKER W/HINGE 2XL
9" COOLTEX WRIST SPLINT W/STRAP XL LF
COOLTEX 13" ANT CL W/ROM HINGE OP POP 3XL
COOLTEX KNEE SLEEVE W/STAYS OPEN PAT XS
TENNIS ELBOW SLEEVE W/PAD 1/8" XL
MARATHON SPEED LACE-UP ANKLE 2XL
13" KNEE SLEEVE 3/16" XL
KNEE WRAP UNIV 1/8"
8" ULTRA FIT COOL WRIST SPLINT S LF
COOLTEX AG 13" KNEE-O-TRAKKER W/HINGES XS
COOLTEX 6" KNEE-O-TRAKKER 3XL
13" ANT CL KNEE WRAP W/HINGE 3/16" M
6" KNEE-O-TRAKKER 2XL
COOLTEX 13" KNEE SL OP POP W/HINGE XL
ULTRA CLAVICLE STRAP L
10" ULTRA FIT WRIST SPLINT XL RT
8" ULTRA FIT COOL WRIST SPLINT W/ABD THUMB M RT
13" KNEE SLEEVE OP PAT 3/16" XS
8" ULTRA FIT WRIST SPLINT S LF
9" COOLTEX WRIST SPLINT W/STRAP M RT
8" SUEDE WRIST LACER SPLINT W/ABD THUMB M RT
13" KNEE-O-TRAKKER W/HINGE 4XL
POEB HOOK ALLIGATOR TAB 1"X2.95"
HOOK BEL-TIP W/KNIT LOOP BLACK 2" X 3"
COOLTEX 16" ANT CL KNEE WRP OP POP W/ROM HNG XL
6" KNEE-O-TRAKKER XS
LG/X-LG VENTRAL LINER
UNIVERSAL LACER WRIST ORTHOSIS W/ABDUCTED THUMB RIGHT
MARATHON SPEED LACE-UP ANKLE M
COOLTEX AG 13" ANTERIOR CLOSURE KNEE WRAP W/HINGE OPEN S
6" COMPRESSION KNEE IMMOBILIZER
6" KNEE-O-TRAKKER W/HINGE 3XL
13" ANT CL KNEE WRAP W/HINGE 3/16" 3XL
10" ULTRA FIT WRIST SPLINT L RT
9" COOLTEX WRIST SPLINT W/STRAP L LF
16" UNIVERSAL KNEE IMMOBILIZER X-WIDE HD STAYS
ULTRA CERVICAL COLLAR 3 1/2" M
16" COMPRESSION KNEE IMMOBILIZER W/POCKETS 0 GELS
9" COOLTEX WRIST SPLINT W/STRAP L RT
COOLTEX 13" ANT CL KNEE WRAP W/HINGE M
COOLTEX AG 13" PAT STAB W/COR-TRAK BUTTRESS/HINGE OPEN L
COOLTEX 13" KNEE SL OP POP W/HINGE 3XL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device