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
Drape, Surgical KKX

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)