15 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08" X 77" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF ( I) TUBE SUCTION CONNECT W' X 12' LIF (2) LITE GLOVE LIF ( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) DRAPE SHEET 41" X 58" SMS LIF ( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF ( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) UTILITY BOWL QUART 32oz LIF ( I) BLADE SURGICAL II CARBON STEEL ( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL ( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41" X 58" SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4" X 4" 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 33" (2) SHEET DRAPE 70" X 100" LIF (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (4) DRAPE UTILITY WIT APE LIF ( 1) COVER CAMERA W/ELAST LIF (2) GAUZE SPONGE 4" X 4" 12PL Y LIF ( 1) NEEDLE ULTRA VERES 120mm LIF (2) DRAPE SHEET 41 " X 58" SMS LIF ( 1) SCALPEL WEIGHTED SAFETY #11 ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF ( 1) DRESSING TEGADERM 4" X 4 %" LIF ( 1) TUBE SUCTION CONNECT X" X 12' LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) SUTURE BAG FLORAL LIF ( 1) Pk. STERI STRIP LAP SET LATEX ( 1) CORD LAPAROSCOPY MONOPOLAR LIF ( 1) MAYO TRAY SMALL LIF ( 1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF ( 1) BAG ZIP LOCK PLASTIC 6" X 10" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42" X 57" SMS (I) TUBE SUCTION CONNECT Y." X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF ( I ) PVP PAINT 8" STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2" ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( I ) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014