3 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK 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
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM 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
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h" X 4" ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110" X 77" SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50" X 90" ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6" WOOD (2) STRJPS TAPE 24" X 4" ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30" X 30" (2) COTTON TIP APPLICATOR 6" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5" X 20" (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT 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