Super Absorbent Dressing 6" x 6" GEN-19360

GUDID 10361554005420

Gentell, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial
Primary Device ID10361554005420
NIH Device Record Key15aeae5a-53dd-40c0-bd5d-7fc24ca522f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Absorbent Dressing 6" x 6"
Version Model NumberGEN-19360
Catalog NumberGEN-19360
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
GS100361554005416 [Unit of Use]
GS100361554005423 [Primary]
GS110361554005420 [Package]
Contains: 00361554005423
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

Devices Manufactured by Gentell, LLC

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10361554003259 - Super Absorbent Adherent Dressing (2x2 in)2025-02-28
00361554003399 - Super Absorbent Dressing (2x2 in)2025-02-28
10361554003464 - Super Absorbent Dressing (4x4 in)2025-02-28
10361554003495 - Super Absorbent Dressing (8 x 8 in)2025-02-28
10361554003501 - Super Absorbent Adherent Dressing (5x5 in)2025-02-28
10361554005420 - Super Absorbent Dressing 6" x 6"2025-02-28
10361554005420 - Super Absorbent Dressing 6" x 6"2025-02-28
00361554000985 - Calcium Alginate Ag (Silver) Dressing (4x8 in)2025-02-26

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