Medifoam H

GUDID 08806129660048

Genewel Co.,Ltd.

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID08806129660048
NIH Device Record Key342e88c5-1058-40fc-bf49-6ebd6e7112be
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedifoam H
Version Model NumberML10010003
Company DUNS987669599
Company NameGenewel Co.,Ltd.
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108806129660000 [Primary]
GS108806129660048 [Unit of Use]
GS108806129660109 [Primary]

FDA Product Code

NACDressing, Wound, Hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-30

Devices Manufactured by Genewel Co.,Ltd.

08806129660048 - Medifoam H2022-11-07
08806129660048 - Medifoam H2022-11-07
08806129660093 - Medifoam2022-11-07 Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasio
08806129660055 - Medifoam H beauty2022-11-07 Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration,
08806129660062 - Medifoam H band2022-11-07

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