DermaGinate/Ag Healogics by DermaRite

GUDID 00714196935120

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00714196935120
NIH Device Record Key7fc683c6-a926-4cad-af27-871644ef7661
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermaGinate/Ag Healogics by DermaRite
Version Model Number93512
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count10
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
GS100714196935120 [Primary]
GS101714196935129 [Unit of Use]

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 Date2020-09-09
Device Publish Date2020-09-01

On-Brand Devices [DermaGinate/Ag Healogics by DermaRite]

0071419693513793513
0071419693512093512

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