ComfortFoam/Ag

GUDID 00714196391025

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID00714196391025
NIH Device Record Key12abea20-701e-4eee-ad59-5c63b6c73c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfortFoam/Ag
Version Model Number49220
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196391025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-17
Device Publish Date2021-09-09

On-Brand Devices [ComfortFoam/Ag]

0071419649660749660
0071419649450449450
0071419649220349220
0071419639106349660
0071419639104949450
0071419639102549220

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