Home GUDID 10190769064874 UrgoTul Contact Layer 2 X 2 inch
Primary DI 10190769064874
Brand UrgoTul Contact Layer 2 X 2 inch
Company URGO MEDICAL NORTH AMERICA, LLC
Model 506487
Catalog number 506487
Device description A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed in a petroleum jelly matrix.
Published 2019-03-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NAC Dressing, Wound, Hydrophilic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NAC Dressing, Wound, Hydrophilic General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10190769064874 Package GS1 30 In Commercial Distribution 00190769064877 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10190769064874 10190769064874 00190769064877 00190769064877 190769064877 0190769064877
GMDN Terms# Term, Definition table Term Definition Exudate-absorbent dressing, hydrophilic-gel, sterile A sterile wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 052758618 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851383003122 Vashe Wound Solution 118 ml container - Flip Cap 00312 2019-12-02 00851383003146 Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container 00314 00314 2020-02-03 00851383003160 Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container 00316 00316 2020-02-07 00851383003177 Vashe Wound Solution 475 ml (16 fl oz) Instillation Container 00317 00317 2020-04-01 00851383003221 Vashe Wound Solution 1 L (34 fl oz) Flip Top Container 00322 00322 2020-04-01 00851383003238 Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container 00323 00323 2020-04-01 00851383003139 Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap 00313 00313 2020-02-03 00851383003634 Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap 00360 2025-11-17 00190769003555 Vashe Sterile Sleeve 00355 00355 2017-07-17 00190769003548 Vashe Wipes Skin Cleansing Solution Kit 00354 00354 2018-03-28 00190769004057 Vashe Wound Solution OTC 00405 00405 2021-12-07 00190769532437 URGOK2 553243 553243 2019-12-26 00190769532468 URGOK2 Lite 553246 553246 2019-12-20 00190769532444 URGOK2 553244 553244 2019-12-20 00190769532451 URGOK2 Lite 553245 553245 2019-12-20 00851383003528 Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap 00352 00352 2020-02-03 00851383003214 Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 00321 00321 2019-12-02 00851383003009 Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300 00300 2019-11-01 00851383003016 Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 00301 00301 2019-11-01 00851383003023 Drawtex Hydroconductive Wound Dressing with LevaFiber 4X4 00302 00302 2019-11-01
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