Calcium Alginate Ag Dressing 6"x6" GEN-13620

GUDID 00361554005317

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00361554005317
NIH Device Record Key0d8c08a1-3582-40bf-90c7-064b5bbad603
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcium Alginate Ag Dressing 6"x6"
Version Model NumberGEN-13620
Catalog NumberGEN-13620
Company DUNS170967876
Company NameGentell, 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 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
GS100361554005294 [Unit of Use]
GS100361554005300 [Primary]
GS100361554005317 [Package]
Contains: 00361554005300
Package: Case [5 Units]
In Commercial Distribution

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 Date2025-02-26
Device Publish Date2025-02-18

Devices Manufactured by Gentell, LLC

00361554002002 - Comfortell Composite Dressing (4x4 in2025-04-04
00361554002033 - Comfortell Composite Dressing (6x6 in)2025-04-04
00361554002903 - Calcium Alginate Dressing Rope (12 in)2025-04-04
00361554001678 - Dermatell Hydrocolloid (Non-Bordered) Wound Dressing (4x4 in)2025-04-03
00361554001708 - Dermatell Hydrocolloid (Bordered) Wound Dressing (4x4 in)2025-04-03
10361554001729 - Dermatell Hydrocolloid (Bordered) Wound Dressing (6x6 in) 2025-04-03
00361554002101 - Gentell FixTape (2x11 yards) 2025-04-03
00361554002125 - Gentell FixTape (4x11 yards) 2025-04-03

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