DermaCol 100 Sheet

GUDID 00714196391353

DERMARITE INDUSTRIES LLC

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing
Primary Device ID00714196391353
NIH Device Record Key8fb864ad-9f8d-4a5f-b1c5-ba685ad30898
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermaCol 100 Sheet
Version Model Number003221
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196391353 [Primary]

FDA Product Code

KGNDressing, Wound, Collagen

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 [DermaCol 100 Sheet]

00714196033413003341
00714196033215003221
00714196391360003341
00714196391353003221

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