18 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/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
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk 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
D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF (1) UTILITY BOWL 32oz. UF (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX (2) DRESSING NON ADH TELFA 4 X 3 ST. UF (1) JELLY LUBRICATING FIVE GRAM (1) TABLE COVER REINFORCED 50" X 90" LIF (1) *Pk. STERI STRIP LAP SET LATEX (1) COVER CAMERA W/ELAST UF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF (4) TOWELS ABSORBENT 15" X 20" UF (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF (2) LIGHT SHIELD (1) DRESSING TEGADERM 4" X 4 %" LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (1) SCALPEL WEIGHTED SAFETY #11 (1) BAG ZIP LOCK (1) Pk. STRIP STERI CLOSURE W' X 4" LIF (1) TIME OUT BEACON NON WOVEN ST. UF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE ULTRA VERES 120MM UF (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER 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
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X 4" 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4" (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60" X 77" REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER 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
General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50" X 90" LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) SYRINGE BULB 60CC LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE HYPODERMIC 18G X 1% LIF (6) TOWEL CLOTH HUCK BLUE LIF (4) DRAPE UTILITY WITH TAPE L/F (1) NEEDLE HYPODERMIC 25 X 1% L/F (1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF (2) NEEDLE SPINAL ANESHT 20G X 3%" LIF (1) SKIN MARKER WITH RULER LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) LITE GLOVE (1) DRAPE BREAST/CHEST SMS LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (10) GAUZE SPONGE 4" X 4" 16PLY L/F (2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE (1) TRAY 3/COMPARTMENT (1) WRAPPER 24" X 24" L/F (2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEX 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
LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (2) LITE GLOVE LIF (1) TUBE SUCTION CONNECTING W X 12' LIF (1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS (1) BLADE SURGICAL #11 STAINLESS STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) BAG SUTURE FLORAL (1) TUR Y SET, 2 LEAD L/F (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) GOWN STANDARD LARGE SMS VELCRO NECK (1) TUBE SUCTION CONNECT 3/16" X 12' LIF (1) Pk. STERI STRIP LAP. LATEX (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL ROCKER SWITCH LIF 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
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF (1) DRAPE % ECONOMY 53" X 77" UF (2) TOWEL ABSORBENT 15" X 20" UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14" X 48" (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1) RULER L/F 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
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~" X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER WITH RULER (2) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST SMS (10) SPONGE LAP PREWASH 18" X 18" XRD (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1) BLADE SURG. #15 CARBON STEEL (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE (10) GAUZE SPONGE 4" X 4" 16PLY (1) PK. STRIP STERI CLOSURE W' X 4" (1) NEEDLE SPINAL ANESTH 22G X 3Y2 (1) NEEDLE HYPODERMIC 22G X 1Y2 (1) IV PRIMARY ADD ADMINISTRAT SET (1) STOPCOCK 3WAY WSWIVEL MALE (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK 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
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4" 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
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION 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
NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17" (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W'X 6" (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF (2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL 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
CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST. (1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz. (1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST. (1) COVER TABLE REINFORCED 50" X 90" (1) SYRINGE 10CC W/0 NEEDLE L/LOCK (1) BOWL PLASTIC W/LID 80oz (2) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET DRAPE 41" X 58" SMS (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" (1) YANKAUER SUCTION TUBE W/0 VENT (1) WRAPPER 30" X 30" (15) SPONGE LAP PREWASH 18" X 18" XRD (1) TIME OUT BEACON NON WOVEN ST. (1) TUBE SUCTION CO NN ECT~" X 12' (2) LIGHT SHIELD (1) GOWN SURG REINF LARGE T/WRAP (2) PK. STRIP STERI CLOSURE W' X 4" (1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4" X 14" (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER 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 COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (10) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN 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
KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION CONNECT. W X 12' LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F (2) BANDAGE ELASTIC 6" X 5yds L/F (4) STRIP TAPE 24" X 4" LIF (1) Pk. STERI STRIP CLOSURE Y:z" X 4" LIF (1) SHEET ARTHROSCOPY "T" STD SMS W/POUCH L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF (2) NEEDLE HYPODERMIC 25 X 1Y:z LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) STOCKINETTE IMPERV. 14" X 48" LIF (1) TABLE COVER REINF. 50" X 90" LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) SAFETY GLIDE NEEDLE 21G X 1% (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV 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 COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (1 0) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. 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
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9" X 48" LIF (1) SPLIT SHEET BILATERAL 84" X 80" LIF (3) DRAPE SHEET 41" X 58" SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM 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