FDA Registration
Active
🇺🇸 United States
PACEMAKER/EP DRAPE W/MICROBAN & DUAL FC POUCHES, 86" X 125"
Reg #: 1058584
·
FEI: 1000219637
·
Expires 2025
Products
1
Proprietary Names
285
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1058584
- FEI Number
- 1000219637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10811 Withers Cove Park Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K980210
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2013-04-18 |
Proprietary Names
PACEMAKER/EP DRAPE W/MICROBAN & DUAL FC POUCHES, 86" X 125"
PATIENT ISOLATION DRAPE, LATEX FREE
TRAUMA DRAPE
SEATTLE C-SECTION DRAPE, LATEX FREE
ARTHRO DRP W/IRR LATEX FREE
FEMORAL ANGIO DRP W/DUAL CIRCULAR FENES, 75" X 110"
*[P/L]CS-#70-2007-3461-7 ARTHR FLUID COLL POUCH
ROBOTIC PATIENT DRP,HYSTERECTOMY,101" X 113 1/2"
CENTRAL LINE/PICC DRAPE, 86" X 110"
VERSA-DRAPE BIOPSY/MINOR PROCEDURES, 21" X 25"
LINGEMAN PERCUTANEOUS NEPHROSCOPY DRAPE W/FC POUCH & SIDE TR
MB & J HIP DRAPE, LATEX FREE
FRANZ ANGIOGRAPHY DRAPE W/RADIATION SHIELD
PACEMAKER DRAPE W/FLUID COLLECTION POUCH, 75" X 130"
*SHOULDER ARTHRO FLUID PCH LATEX FREE
*#8514 NEO NATAL DRAPE, 89" X 128"
SPECIAL PROCEDURES/P.I.C.C. DRAPE, 75" X 125''
*LG APERTURE DRP W/FL PCH LATEX FREE
ANGIOGRAPHY DRAPE W/RADIATION PROTECTION AND POUCHES
CV DRAPE
SPECIAL PROCEDURES DRAPE W/CIRC APERTURE, 75" X 80"
ABSORBENT 3/4 SHEET, 50" X 48" (127CM X 122CM)
RUSSELL/TAYLOR ISOLATION DRAPE (6/EA)
MULTI PURPOSE FLUID COLLECTION POUCH
LINGEMAN TUR PACK WITH UNDERBUTTOCKS POUCH DRAPE
*[P/L]GLASSCOCK OTOLOGY SURGERY DRAPE W/ MICROBAN INCISE
*PATIENT ISOLATION DRAPE
PATIENT ISOLATION DRAPE, 96" X 130"
EAR DRAPE LATEX FREE
FISTULA DRAPE
PATIENT ISOLATION DRP 96X130 LATEX FREE
ANGIOGRAPHY DRAPE W/ ABS TROUGH, 86" X 135"
PACEMAKER DRAPE W/SINGLE RECTANGULAR FENES 86" X 135"
EAR DRAPE LAMINATED LARGE (6/EA)
FEMORAL DUAL ACCESS RADIAL DRAPE
ANESTHESIA SCREEN W/ADHESIVE, 126" X 96" LATEX FREE
*PEDIATRIC CRANIOTOMY DRAPE W/MICROBAN & PER.POU 88" X 128"
PACEMAKER DRAPE
*POLYFOAM EAR DRAPE W/SLIT
HYSTEROSCOPY/D&C DRAPE
*PEDIATRIC DRAPE, 89" X 128"
VERTICAL ISOLATION DRP W/ MICROBAN FEATURING PERFECT POUCH
HYSTEROSCOPY/LAPAROSCOPY DRAPE,98X101.5"
ADULT/PEDIATRIC ANGIOGRAPHY DRAPE,75" X 125"(191 CM X 318CM)
LINGEMAN ENDO BLADDER SUSPENSION DRAPE
*[P/L]EMBOSSED PLASTIC DRP W/RECTANGLE INCISE
IMAGE BOOT, LATEX FREE
*[P/L]PATIENT ISOLATION DRP SAMPLES,LATEX FRE
ANGIOGRAPHY DRAPE W/EXTRA ABS PATCH
PEDIATRIC/THYROID ANGIO DRAPE, 75IN X 12IN
DRAPE ARMOUR LOW FREE POSITIONAL SHIELD
*MULTI PURPOSE FLUID COLLECTION POUCH
PACEMAKER/EP STUDIES DRAPE W/MICROBAN
DELUXE ISOLATION DRP W/INCISE FEATURING MICROBAN& FL PCH
*SPECIAL PROCED DRAPE W/SQUARE FENES 75"X 45"
*{P/L} OPHTHALMIC SURGICAL DRAPE, APERTURE, 2 FL POUCHES,N/W
CRANIOTOMY DRAPE W/MICROBAN & FC PCH, 77" X 85"
LUMBAR LAMINECTOMY DRP,TRAUMA FOLD,LX/FR
PACEMAKER/EP DRAPE W/MICROBAN & DUAL FC POUCHES, 100 X 144
DRAPE ARMOUR SPECIAL PROCEDURES DRAPE, 43 X 54"
ARTHR DRP W/FLO IRR PCH 77" X 120"
BILATERAL ARTH DRP W/PCH, LATEXREE
OCULAR OCCLUDERS
*EYE DRP W/APERTURE/FL PCH,LATEX FREE
KNEE ARTHROSCOPY DRAPE FEATURING PERFECT POUCH
FISTULAGRAM DRP, 38 1/2" X 60" W/OVAL FENE, STERILE, #9235
PACEMAKER DRAPE W/DELNET&SINGLE RECTANGULAR FENES 86" X 135"
PACEMAKER/EP DRAPE
ROBOTIC PATIENT DRAPE, HYSTERECTOMY
*ADULT SHUNT DRAPE, LATEX FREE
SPECIAL PROCEDURES DRAPE W/CIRC APERTURE, 75" X 105"
*ARMATEC ISOLATION/TRANSPORT DRAPE
Trough Pouches
PEDIATRIC/NEO-NATAL ANGIOGRAPHY DRAPE, 75" X 135"
Multi Access Fe/Radial Drape
*PREP DRAPE
PENN. HOSP. ISOLATION DRP,LATEX FREE
PATIENT ISOLATION DRP SYS, LATEX FREE
CRANIOTOMY DRP W/PCH 152X106,LATEX FREE
*[P/L]CHK.PAT.ISO.DRP.W/IRR.POU./I/P
*ARTHL/COLL PCH LATEXREE
DRAPE ARMOUR FREE POSITIONAL SHIELD-L-SHAPED, 16"X13"X8"
DRAPE ARMOUR FREE POSITIONAL SHIELD, 16" X 14"
*UNIV. CATARACT DRP PACK, LATEX FREE
[P/L]VERTICAL ISOLATION DRP W/MICROBAN, 96" X 130"
FEMORAL ANGIO DRAPE W/DELNET W/DUAL CIR FENES, 86" X 135"
*HIP DRAPE
*[P/L]DRESSING, STERILE, UNIV
IMAGE INTENSIFIER ISOLATION DRAPE(6/EA)
EYE DRAPE LATEX FREE
*[P/L]APERTURE PCH DRP,WILSON 515-OAP1627-10
SPECIAL PROCED DRAPE W/DELNET W/DUAL APERTURE FEN 75" X 30"
SPECIAL PROCEDURES PEDIATRIC DRAPE W/2" APER,38 1/2IN X 55IN
CENTRAL LINE/PICC DRAPE, 48" X 96"
*[P/L]PATIENT ISO DRP W/MICROBAN INCISE ,130" X 96"
HYSTEROSCOPY DRAPE W/TUBING
SCROTAL DRAPE
ABSORBENT 3/4 SHEET, 50" X 102" (127CM X 259CM)
ANGIO/I.J. DRAPE COMBINATION
Angiography/PICC Drape
VERSA-DRAPE FOR ANGIOPLASTY/INTERVENT PROCEDURES
LINGEMAN LITHOTOMY ENDOSCOPY DRAPE W/BUILT IN UBD
*[P/L]APERTURE DRAPE, 40" X 48",515-OAP4048-1
*ANGIO DRAPE, 83" X 140"
EYE/EAR DRAPE LAMINATED SMALL (18/EA) 18" X 18"
C-BIRTH POUCH, LATEX FREE
PEDIATRIC/THYROID ANGIO DRAPE, 75" X 125"
UNDERBUTTOCKS DRAPE
E.P/PACEMAKER W/RADIATION PROTECTION
ACL RECONSTRCTN DRP F/EXTENDED KNEE POS
NEURO DRAPE, LATEX FREE
DRAPE ARMOUR LOW LARGE FREE POSITIONAL PROTECT
FENESTRATED DRAPE W/TAPE,#9127,32''X28", 50/CASE
*CARDIOVASCULAR W/TROUGH POUCHES AND CORD TIES,100" X 134"
*[P/L]ADHERENT WINDOW SHEET W/INCISE, 41" X 43"
FEMORAL ANGIO DRAPE W/DELNET W/DUAL CIRC FENES, 75" X 125"
IRRIGATION POUCH, LATEX FREE
URO DRAIN BAG II W/8" CUFF
Femorla/Dual Angiography Drape 86" x 135"
LINGEMAN PERCUTANEOUS PROCEDURE DRAPE
*#905 BRACHIAL DRAPE 38 1/2" X 60", STERILE
SPECIAL PROCEDURES DRAPE W/PATIENT VIEW WINDOW, 75" X 145"
[P/L] LATERAL POSITION PACK
PERI/OB POUCH DRAPE LATEX FREE
QUINN UNIV TMJ ARTHR DRP, LATEX FREE
*ARTHROS DRP W/IRR PCH, LATEX FREE
SHOULDER ARTHROSCOPY DRAPE LATEX FREE
FLUID COLLECTION POUCH LATEX FREE
*{PL} MB & HIP DRP, LATEX FREE
EYE OR EAR DRAPE LAMINATED (6/EA) 48" X 32"
*GLASSCOCK NEUROTOLOGY DRAPE, LATEX FREE
*[P/L] UNIVERSAL ANGIO DRAPE #8669 86" X 135" W/FL RH & LH
DUAL LAPAROSCOPY INSTR PCH, LATEX FREE
DEL PATIENT ISOLATION DRP, LATEX FREE
SPECIAL PROCEDURES W/MICROBAN & DUAL FC POUCH , 100" X 150"
*#8512 PEDIATRIC DRAPE 89" x 140"
FEMORAL ANGIO DRP W/DUAL CIRC FENES, 86" X 135"
PACEMAKER DRP W/DUAL FENES, 75" X 125"
FOUR (4) PIECE SPECIAL PROCEDURES DRAPE W/FC POUCHES
LINGEMAN 3 IN 1 DRAPE FEATURING PERFECT POUCH
BEACH CHAIR SHOULDER DRAPE FEATURING PERFECT POUCH
BILATERAL OPTH. DRAPE,CLEAR(12/EA) 32" X 50"
OPHTHALMIC POUCH, LATEX FREE
*[P/L]BAV/CAV STEREO DRAPE, 48" X 56"
*UNIV TMJ ARTH DR.W.FL PCHES,LATEX FREE
*KIDNEY ACCESS/SPECIAL PROCEDURES DRAPE W/FC POUCH, 75 X 140
SPECIAL PROCED DRAPE W/DELNET W/SINGLE OVAL FENES 75" X 60"
CRANI DRP W/8" FENS INCISE LATEX FREE
PLASTIC DRAPE
LINGEMAN PERCUTANEOUS PROCEDURE DRAPE
*[P/L ]POUCH DRAPE,WILSON 515-0NP1627-10
DRAPE ARMOUR LOW SMALL FREE POSITIONAL PROTECT SHIELD
EAR & EYE DRAPE LATEX FREE
FEMORAL ANGIO DRAPE W/DUAL CIRCULAR FENES, 75" X 125"
*[P/L]UPPER EXTREMITY DRAPE
ADULT CRANIOTOMY DRP,TRAUMA FOLD,LX/FREE
IJ ACCESS/RADIOLOGY DRAPE, 75" X 125" (191CM X 318CM)
*FEMORAL DRAPE W/WINDOW
*SPECIAL APERTURE DRAPE, 16" X 16"
OPEN HEART DRAPE W/MICROBAN , 135" X 148"
*ANESTHESIA SCREEN 60X85 W/ADH LATEX FRE
*{P/L} OPHTHALMIC SURGICAL DRAPE, APERTURE, 2 FC POUCHES,N/W
LATERAL POSITION SHOULDER DRAPE SYSTEM FEAT PERFECT POUCH
APERTURE POUCH DRAPE W/WITHOUT POUCHES
*UNILATERAL TMJ ARTH DRP, LATEX FREE
[P/L] LUMBAR LAMINECTOMY DRAPE
*[P/L]EXTREMITY DRAPE W/MICROBAN
PACEMAKER/EP DRAPE W/DIAMOND FENES, 86" X 135"
HFS EAR DRAPE LAMINATED (6/EA)
LINGEMAN GYN SURGERY PACK
SPECIAL PROCED DRAPE W/OVAL APERTURE, 32" X 42"
*[P/L]ADULT CRANIOTOMY DRAPE - PHELAN FOLD
CRANIOTOMY DRP 152"X106" LATEX FREE
*ANGIOGRAPHY DRAPE SYSTEM
DRAPE ANGIO W/ CUSTOM TROUGH, 86" X 135"
*LIMB ISOLATION DRAPE, LATEX FREE
CESAREAN DRAPE W/MICROBAN FC POUCH, 100" X 124"
GYN/CYSTO POUCH DRAPE LATEX FREE
Trough Fluid Pouches
*[P/L]VERTICAL PATIENT ISO DRAPE W/MICROBAN INCISE ADHESIV
FEMORAL/RADIAL ANGIOGRAPHY DRAPE
DRAPE ARMOUR SMALL FREE POSITIONAL PROTECT SHIELD,16" X 11"
FEMORAL ANGIO/IJ ACCESS COMBINATION DRAPE, 75" X 145"
ARTHROSCOPY DRP W/IRR/PCH, LATEX FREE
CENTRAL LINE/PICC DRAPE, 77" X 120"
SPECIAL PROCED DRAPE W/DELNET W/SINGLE OVAL FEN 75" X 30"
EPD DRAPE, 86" X 125"
XL FREE POSITIONAL SHIELD, L-SHAPE
Special Procedure/Angio Drape W/dual FC Pouches
*[P/L]GLASSCOCK NEUROTOLOGY DRAPE W/ POUCHES & MICROBAN INC
*CATARACT DRAPE SYSTEM, LATEX FREE
*FEMORAL ANGIO DRAPE W/MALLEABLE BARS AND OVAL FENES, 86" X
UROLOGICAL DRAIN POUCH W/SUCTION HOSE
*[P/L]WILSON(515-OAB2836-10)SPECIAL APERTURE DRAPE
*EYE DRP W/3" FENESTRATION,LATEX FREE
CIRCUMCISION DRP 20"X12" LATEX FREE
PACEMAKER DRAPE W/DELNET 75" X 125" W/DUAL SQUARE FENES
*SPECIAL PROCEDURES DRAPE W/PATIENT VIEW WINDOW, 75IN X165IN
DRAPE ARMOUR LARGE FREE POSITIONAL SHIELD,16"X13"(8" CUT)
*UROLOGY BAG W/SUCTION HOSE,LATEX FREE
DRAPE ARMOUR LARGE FREE POSITIONAL PROTECT SHIELD,16"X16"
PACEMAKER DRAPE W/MICROBAN& DRAPE
*LUMBAR LAMINECTOMY DRAPE, PHELAN FOLD
#990 MYLEOGRAM DRAPE, 26 1/2" X 21" W/TAPE, STERILE
LINGEMAN 3 IN 1 DRAPE
PACEMAKER DRAPE W/DUAL ABSORBENT POUCHES, 75" X 135"
*BILATERAL ARTHROSCOPY DRP, LATEX FREE
*EYE DRAPE W/IRRIGATION POUCH
PACEMAKER DRP W/DELNET W/DUAL FENES, 86" X 135"
PERI/OB POUCH DRAPE
PACEMAKER DRAPE W/DUAL ACCESS W/MICROBAN, 86" X 125"
DRAPE ARMOUR SMALL U-SHAPE FREE POSITIONAL SHIELD,16"X13"
FEMORAL/RADIAL ANGIO DRAPE
ROBOTIC PATIENT DRAPE, PROSTATECTOMY,101" X 151 1/2" W/TROUG
*ADULT CRANIOTOMY DRAPE W/MICROBAN FEATURING PERFECT P
KOSLIN BILATERAL TMJ ARTHR.DRP, LATEX FR
FLUID COLLECTION POUCH
KOSLIN UNILATERAL TMJ ARTH DRP,LATEX FRE
CESAREAN BIRTH DRP FEATURING PERFECT POUCH
GLASSCOCK EAR DRAPE, LATEX FREE
*[P/L: ]APERTURE DRAPE,WILSON 515-OAA4048-10
IJ ACCESS/RADIOLOGY DRAPE W/FC POUCH, 75" X 125"
LINGEMAN GYN SURGERY DRAPE
*UNIVERSAL ANGIO DRAPE,191cm X 279cm, W/FULL RH & LH WINDOW
DRAPE ARMOUR SPECIAL PROCEDURES DRAPE, 86 X 135"
MEDIUM DRAPE W/INCISE, 50" X 48",LATEX FREE
PACEMAKER DRP W/DUAL FENES, 86" X 135"
*UNIV TMJ ARTH DRP W/FL COLL PO
EYE/EAR DRAPE,EMBOSSED, PLAIN SMALL (36/EA) 18" X 20"
PERI/GYN UNDERBUTTOCKS DRAPE
CRANIOTOMY DRAPE, LATEX FREE
*#9217 BRACHIAL DRAPE, 38 1/2" X 60"
UNDERBUTTOCKS DRAPE W/POUCH W/O NOZZLE
ANGIOGRAPHY DRAPE W/DUAL SIDE PANELS & FC POUCH, 86"X 135"
*SPECIAL PROCEDURES DRAPE W/MICROBAN, 86IN X 135IN
LAMINATED EYE DRAPE, SMALL 18" X 18"
*PATIENT ISOLATION DRAPE *LATEX FREE*
VERSA-DRAPE FOR ANGIOPLASTY/INTERVENT PROCEDURES, 86" X 135"
*SPECIAL PROCEDURES/ANGIO DRAPE W/DUAL FC POUCHES, 86"X145"
EAR DRAPE, PLAIN (36/EA)
*CATARACT DRP (INCISE) LATEX FREE
*CUSTOM CYSTOSCOPE DRAPE 72" X 72"
*PANEL DRP W/ADH ,30" X 24" ,LATEX FREE
Dual Femeral and IJ Access Drape W/Dual FC PCHS
DRAPE CUSTOM PACING W/TROUGH, 86" X 135"
PATIENT ISOLATION DELUXE VERTICAL DRP W/MICROBAN
FEMORAL ANGIOGRAPHY DRAPE
PEDIATRIC 3-PIECE SHUNT DRP,LATEX FREE
SPECIAL PROCEDURES DRAPE, 43" X 45"
*ACL RECONSTRUCTION DRAPE F/FLEXED KNEE POS
*VERTICAL ISOLATION DRAPE, W/C ARM GUSSE
SPECIAL PROCEDURE DRAPE, 86" X 125"
LINGEMAN UNIVERSAL CYSTO DRAPE, 126" X 105"
*ADULT/PEDIATRIC ANGIOGRAPHY DRAPE, 75" X 133"(191CM X318CM)
UNIVERSAL ANGIO DRAPE, 218CM X 343CM W/EXTRA ABSORBENT
*NEUROSURGICAL DRP PACK, LATEX FREE
*SPECIALTY PROCEDURES DRAPE W/INSTR HOLDER. 75" X 116"
SHEA EAR DRAPE
UNIVERSAL ANGIO DRAPE, 191 CM X 318 CM W/FL RH&LH WINDOW
ROBOTIC PATIENT DRAPE, PROSTATECTOMY,101" X 151 1/2"
LINGEMAN 3-IN-1 PACK
*[P/L]PATIENT ISOLATION DRAPE FOR OSI
ADULT CRANIOTOMY DRAPE W/ 14" FENESTRATION
PACEMAKER DRAPE W/DUAL APERT. AND DUAL FC POUCHES, 86" X 133
*DO IT YOURSELF DRAPE, (6/EA)LARGE LAMINATED
*TMJ ARTH FLUID COLL PCH, LATEX FREE
CENTRAL LINE/PICC DRAPE, 86" X 110" WITH PERF
KYPHOPLASTY/VERTEBOPLASTY DRAPE W/RADIATION SHIELD
UROLOGICAL DRAPE W/FINGER COT, LATEX FREE, 24" X 36"
BRACHIAL DRAPE
SPECIAL PROCED DRAPE W/SINGLE OVAL FENES 75" X 60"
LINGEMAN GYN SURGERY DRAPE FEATURING PERFECT POUCH
ANGIOGRAPHY DRAPE W/RADIATION PROTECTION, 75IN X 125IN
*CHRONIC EAR DRAPE & FLUID COLLECTION POUCH
*LAMINATED EYE DRAPE, LARGE (6/EA)
*[P/L]CATARACT DRAPE
*ARTHROSCOPY DRAPE, LATEX FREE
*OPHTHALMIC DRAPE, LATEX FREE
LINGEMAN TUR PACK
SHEA EAR DRAPE (6/EA)
SPECIAL PROCEDURES DRAPE, 75" X 135"
LINGEMAN TUR DRAPE W/LATEX FREE FINGER COT
*[P/L]STERILE COMPOSITE DRESSING
ADULT CRANIOTOMY DRAPE, LATEX FREE
VERSA-DRAPE FOR BIOPSY/MINOR PROCEDURES, 43" X 45"
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)