Calcium Alginate Dressing (6x6 in) GEN-13700

GUDID 00361554000923

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID00361554000923
NIH Device Record Key0d4e632e-d250-4293-acfd-92606ed9cfe1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcium Alginate Dressing (6x6 in)
Version Model NumberGEN-13700
Catalog NumberGEN-13700
Company DUNS170967876
Company NameGentell, LLC
Device Count10
DM Exempttrue
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
GS100361554000909 [Unit of Use]
GS100361554000916 [Primary]
GS100361554000923 [Package]
Contains: 00361554000916
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 Date2025-02-24
Device Publish Date2025-02-14

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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