AquaRite Extra CMC

GUDID 00714196406606

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID00714196406606
NIH Device Record Key57306eaa-4c8b-47af-a7a5-109f183af7a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquaRite Extra CMC
Version Model Number40660
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count5
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196406606 [Primary]
GS101714196406605 [Unit of Use]

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

On-Brand Devices [AquaRite Extra CMC]

0071419640660640660
0071419640450340450
0071419640318640318
0071419640220240220
0071419639012740660
0071419639010340450
0071419639008040318
0071419639006640220

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