Super Absorbent Adherent Dressing (8x8 in) GEN-19480

GUDID 10361554001279

Gentell, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial
Primary Device ID10361554001279
NIH Device Record Keya727389a-0afc-47ed-93a5-bd51cf099db9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Absorbent Adherent Dressing (8x8 in)
Version Model NumberGEN-19480
Catalog NumberGEN-19480
Company DUNS170967876
Company NameGentell, LLC
Device Count10
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100361554001265 [Unit of Use]
GS100361554001272 [Primary]
GS110361554001279 [Package]
Contains: 00361554001272
Package: Case [5 Units]
In Commercial Distribution

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 Date2025-02-28
Device Publish Date2025-02-20

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