Super Absorbent Dressing (2x2 in) GEN-19320

GUDID 00361554003399

Gentell, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial
Primary Device ID00361554003399
NIH Device Record Key169e890b-1021-46be-832f-e2a84297840b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Absorbent Dressing (2x2 in)
Version Model NumberGEN-19320
Catalog NumberGEN-19320
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
GS100361554001142 [Unit of Use]
GS100361554003382 [Primary]
GS100361554003399 [Package]
Contains: 00361554003382
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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