FDA Registration
Active
🇺🇸 United States
STRAP ELASTIC BLACK 3"X12"
Reg #: 1218997
·
FEI: 1218997
·
Expires 2025
Products
1
Proprietary Names
179
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- CORFLEX
- Registration Number
- 1218997
- FEI Number
- 1218997
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 669 EAST INDUSTRIAL PARK, DRIVE
- City
- MANCHESTER
- State
- NH
- ZIP
- 03109
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2001-10-12 |
Proprietary Names
STRAP ELASTIC BLACK 3"X12"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 30"
ULTRA SHOULDER ABD PILLOW SM/MED
STRAP W/LOOP-LOC & VEL-LOOP 1"X29"
ULTRA ARM SLING XS
STRAP ELASTIC BLACK 3"X10"
STRAP BLK 2 X 15" (NO LOOP LOC)
3MM AIRMESH NS BLK 59/60"
RANGER AP FRAME PAD
61MM BLK POLYURENTHANE BALL W/LOGO
ECONOMIZER SHOULDER IMMOBILIZER L
DALC 9" COOLTEX WRIST SPLINT W/ STRAP IFU
SHOULDER ABD PILLOW W/FIRM FIT SLING L
BLACK TRICOT SHOULDER IMMOBILIZER L
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 24"
PADDED STRAP SLING XS
PALMAR STAY 2 BEND 1" X 6.75"
COLLAR & CUFF SLING
FACE STRAP WHITE 1.5 X 10.5" (12.5" overall length)
STRAP BLACK 2 X 22"
SLING PADDED STRAP BLUE FOAM W/HOOK 40"
STRAP WHITE #255701 2 X 15"
BLACK TRICOT ARM SLING S
SUPPLY CHAIN MISC ORDERS
BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 8"
BLACK ELASTIC W/1" HOOK 1.5 X 5.5"
ELASTIC SHOULDER IMMOBILIZER S
UNIVERSAL COMFORT SHOULDER IMMOBILIZER
ULTRA SHOULDER IMMOBILIZER W/PAD M
ULTRA ARM SLING W/PAD XS
3" x 14.5" PERF ELASTIC STRAP MD-L
ECONOMIZER ARM SLING XS
BLACK TRICOT ARM SLING M
STRAP ELASTIC BLACK 3"X8"
TEMP MATERIAL SUBSTITUTION NOTE 2.125" X 5.5"
ELASTIC SHOULDER IMMOBILIZER XL
ELASTIC SHOULDER IMMOBILIZER L
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 36"
BLACK TRICOT SHOULDER IMMOBILIZER XL
SHOULDER ABD PILLOW W/FIRM FIT SLING S
BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 5.5"
ULTRA SHOULDER ABDUCTION PILLOW W/SLING L
ECONOMIZER ARM SLING L
EXTENDED + MID LENGTH HUMERAL STRAP
STRAP BLACK 2 X 20"
ELASTIC SHOULDER IMMOBILIZER 2XL
PADDED STRAP SLING XL
FACE STRAP BLACK 1.5"X10"
FACE STRAP BLACK 1.5 X 8" (10.5" overall)
3" x 16.5" PERF ELASTIC STRAP 3XL
PADDED STRAP SHOULDER IMMOBILIZER UNIVERSAL
ULTRA ARM SLING M
SHOULDER ABD PILLOW BALL HOLDER W/BALL
STRAP BLACK 2"X14.5"
HOOK TONGUE BLACK 2 X 3"
ULTRA SHOULDER IMMOBILIZER W/PAD L
RANGER GS SHOULDER ABDUCTION BRACE
HOOK BEL-TIP W/KNIT LOOP BLACK 2 X 2"
RANGER II COMFORT HARNESS W/PADS
ER SHOULDER WEDGE AND STRAP
RANGER GS FRAME COVER W/PADDED WAISTBAND
RANGER SHOULDER IMMOBILIZER
FIRM FIT SHOULDER ABDUCTION PILLOW
PADDED STRAP SHOULDER IMMOBILIZER XL
ULTRA ARM SLING W/PAD M
ECONOMIZER SHOULDER IMMOBILIZER XL
ULTRA ARM SLING XL
3" x 12.5" PERF ELASTIC STRAP XS-SM
ULTRA SHOULDER IMMOBILIZER XL
ULTRA ARM SLING W/PAD L
BLACK TRICOT ARM SLING XL
3" x 15.5" PERF ELASTIC STRAP XL-2XL
STRAP BLACK 2 X 18"
ULTRA SHOULDER IMMOBILIZER W/PAD XL
STRAP WHITE #255708 1 X 8.5"
LEO G. STEIN LOOP DOUBLE FACED (3610) BLK 1.5"
STRAP BLK 2 X 22" (NO LOOP LOC)
STRAP W/LOOP-LOC & VEL-LOOP 1"X21"
FACE STRAP WHITE 1.5 X 7" (9.5" overall length)
BLACK TRICOT SHOULDER IMMOBILIZER S
ULTRA SHOULDER ABDUCTION PILLOW W/SLING XL
ULTRA SHOULDER ABD PILLOW LG/ X-LG
8" COOLTEX THUMB SPICA W/ STRAP IFU
STRAP W/LOOP-LOC & VEL-LOOP 1"X25"
RANGER SLING AND SHOULDER IMM IFU (21-1960/23-1960)
LOOP 1"X1" WITH 1" LOOP LOC - BLACK
ULTRA ARM SLING 2XL
ECONOMIZER ARM SLING M
STRAP BLACK 2 X 30"
BLACK TRICOT SHOULDER IMMOBILIZER XS
POEB HOOK BLACK METAL CUFF 3" X 1.5"
ELASTIC SHOULDER IMMOBILIZER M
HOOK 65 TONGUE BLACK 1.5" X 2.5"
ULTRA ARM SLING S
ELASTIC SHOULDER IMMOBILIZER 3XL
ULTRA SHOULDER IMMOBILIZER M
ELASTIC SHOULDER IMMOBILIZER XS
ACETAL D-RING BLACK 1.5"
WHEATON STRAP 12"
RANGER SHOULDER SLING BODY
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 16"
BLACK MOLDED HOOK TAB W/KNIT LOOP 1.25"x2.5"
STRAP POLYCAST WHITE 1 X 9"
CONTENDER POST-OP ELBOW REPLACEMENT SLING UNIV
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 34"
STRAP W/LOOP-LOC & VEL-LOOP 1"X27"
EZ TAB BLACK 2 X 4"
STRAP W/LOOP-LOC & VEL-LOOP 1"X23"
PADDED STRAP SLING UNIVERSAL
CORFLEX LACE ALIGN TLSO PANEL HOOD & COVER FABRIC ONLY
STRAIGHT STAY 1/2" X 6"
LOOP 1.5"X1" WITH 1.5" LOOP LOC - BLACK
ULTRA SHOULDER IMMOBILIZER W/PAD S
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 28"
FACE STRAP WHITE 1.5 X 8" (10.5" overall length)
STRAP WHITE #255706 2 X 22" (25" overall)
SHOULDER ABD PILLOW W/FIRM FIT SLING XL
RANGER GS SPLINT FRAME W/COVER
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 26"
ULTRA SHOULDER IMMOBILIZER L
PALMAR STAY 2 BEND 1" X 7.5"
ULTRA SHOULDER ABDUCTION PILLOW W/SLING M
HOOK 88 TONGUE BLACK 1.5" X 2.5"
WAIST PADDED STRAP BLUE FOAM W/HOOKS 33"
SHOULDER ABD PILLOW W/FIRM FIT SLING M
HOOK ALLIGATOR TAB W/KNIT LOOP 1" X 1.25"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 14"
STRAP BLACK 2 X 34"
STRAP W/LOOP-LOC & VEL-LOOP 1"X18"
LDPE 1/8" X 24" X 24" WHITE
UNIVERSAL SLING & SWATHE
STRAP BLACK 2 X 28"
RANGER SHOULDER ABDUCTION PILLOW WITH SLING
WHEATON STRAP 08"
RANGER GS SHOULDER ABD BRACE IFU (23-2360)
RANGER II SHOULDER ABDUCTION PILLOW W/SLING
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 20"
RANGER SHOULDER SLING
STRAP ANGLE CUT BLACK 1"X9"
ECONOMIZER SHOULDER IMMOBILIZER S
ULTRA SHOULDER IMMOBILIZER W/PAD XS
1.5" X 2" LOW PROFILE HOOK TAB W DEADENED TIP
ECONOMIZER ARM SLING 2XS
BLACK ELASTIC W/1" HOOK 1.5 X 6.5"
RANGER SLING CUFF DIE CUT BODY
PADDED STRAP SHOULDER IMMOBILIZER XS
BLACK TRICOT ARM SLING XS
ULTRA SHOULDER IMMOBILIZER S
STRAP BLACK 2 X 26"
ULTRA SHOULDER IMMOBILIZER XS
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 22"
STRAP W/LOOP-LOC & VEL-LOOP 1"X16"
ECONOMIZER ARM SLING S
WHEATON STRAP 10"
ECONOMIZER SHOULDER IMMOBILIZER M
ECONOMIZER ARM SLING XL
RANGER II GS SHOULDER ABD BRACE IFU (23-2560)
BLACK ELASTIC W/1" HOOK 1.5 X 5"
ULTRA SHOULDER ABDUCTION PILLOW W/SLING S
FACE STRAP BLACK 1.5 X 9" (11.5" overall)
STRAP BLK 2 X 24"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 18"
STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 32"
ULTRA ARM SLING W/PAD XL
BLACK ALLIGATOR TAB W/KNIT LOOP 1.25"x3"
FACE STRAP WHITE 1.5 X 9" (11.5" overall length)
RANGER SLING STRAP KIT
SPACER MESH BLACK 100 58" WIDTH
ULTRA ARM SLING L
STRAP BLACK 1"X8.5"
RANGER PILLOW
STRAP WHITE 2" X 12 1/2"
ULTRA ARM SLING W/PAD S
RANGER UNIVERSAL SLING
ULTRA SHOULDER IMMOBILIZER 2XS
BLACK TRICOT ARM SLING L
STRAP ANGLE CUT BLACK 1.5"X10"
2" X 2" LOW PROFILE HOOK TAB W DEADENED TIP
BLACK TRICOT SHOULDER IMMOBILIZER M
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device