6 results
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6ms
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Sources: EU EUDAMED, US FDA
LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50" X 90" ( I) MAYO STAND COVER REINFORCED ( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH (2) DRAPE SHEET 42" X 55" SMS 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 - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL 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
LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES 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
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES 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
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