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

10361554001279 - Super Absorbent Adherent Dressing (8x8 in) 2025-02-28
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
00361554000985 - Calcium Alginate Ag (Silver) Dressing (4x8 in)2025-02-26

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.