4 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (3) LITE GLOVE LIF (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" (1) BLADE SURGICAL# 11 (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SUTURE BAG FLORAL L/F (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF (1) CABLE LAP 10FR 4MM MALE MONOP. LIF (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (1) WRAPPER 24" X 24" LIF (1) ULTRA VERES NEEDLE 120MM LIF (1) TROCAR ENDO.XCELL DILATING TIP 11 MM (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF (1) CANNULA 5MM XCEL SLEEVES LIF (2) DENTURE CUP 8oz W/LID (2) DRESSING NON ADH TELFA 4" X 3" (1) CHLORAPREP 26ML APPLICATOR TEAL 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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024