72 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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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
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
CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) SYRINGE EAR/ULCER 2oz. L/F (1) BLANKET BABY PRINTED (1) TUBE SUCTION CONNECT Y-1" X 12' LIF (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) BLANKET RECEIVING 100% COTTON (1) BOWL W/LID PLASTIC 80oz. (1) UMBILICAL CORD CLAMP (1) TUBE FEEDING PVC 8FR 15" LONG (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BAG SUTURE FLORAL (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE (1) SCALPEL W/HANDLE #1 0 (1) SCALPEL W/HANDLE #20 (2) BOWL UTILITY 16oz. LIF (1) PVP PAINT 8" STICK SPONGE LIF (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) SCISSOR UMBILICAL 4.5" STRAIGHT (1) WRAPPER 24" X 24" LIF (1) PVP SCRUB 8" STICK SPONGE LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) TIME OUT BEACON NON WOVEN 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
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
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 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
ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT (2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" (5) ABSORBENT TOWELS 15" X 20" (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV (4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH (5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE (2) DRAPE SHEET 70" X 100" STD SMS (1) TIME OUT BEACON NON WOVEN (1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG (1) TOP DRAPE W/ADHES. 100" X 53" SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP (2) BANDAGE ELASTIC 6" X 5"yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK (1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2 (2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 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
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50" X 90" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F (5) TOWELS ABSORBENT 15" X 20" UF (1) STOKINETIE IMPERVIOUS 14" X 48" LIF (2) DRAPE SHEET 70" X 100" LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF (1) DRAPE INCISION 23" X 17" 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
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
FDA Enforcement
Class I
·Terminated·Atossa Genetics, Inc.·November 6, 2013
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70" X I 00" LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ( I) MAYO TRAY LARGE LIF ( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F (2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23" X I 7" L/F (I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF (2) ABDOMINAL PAD 8" X 7.5" L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F (I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ( I) IMP. STOCKINETTE LIF (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF (2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF (I) SURGICAL BLADE #20 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
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
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
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4" X 4" 16PLY (3) DRAPE '!. ECONOMY 53" X 77" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36" X 77" W/ADl-1. (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18" X 18" XRD (I) COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE 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