Gentell

GUDID 00361554007182

GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm)

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00361554007182
NIH Device Record Keybe1df32f-2a8a-4151-a32d-0f37ae46aa09
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentell
Version Model NumberGEN-13066
Company DUNS170967876
Company NameGentell, LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100361554007182 [Unit of Use]
GS100361554007274 [Primary]

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 Date2025-09-03
Device Publish Date2025-08-26

On-Brand Devices [Gentell]

00361554003184Collagen Dressings 4"X4"
00361554003207Collagen wound dressing, 7"x7"
00361554003153Collagen wound dressing 2"x2"
00361554000787Collagen Particles Wound Filler 1 gram Pouch
20361554000088XXXXXX
10361554003051XXX
10361554000135Collagen wound dressings 7"x7"
10361554000081XXXX
10361554002047xxxx
00361554003863Silicone Bordered gauze 8inx8in
00361554003856Silicone Bordered Gauze 6inx6in
00361554003818Silicone Bordered Gauze 4in x 4in
00361554003771Honey Hydrogel Dressing 7in x5in
00361554003764Honey Hydrogel Dressing 4.7in x3.4in
00361554003733Honey Hydrogel Dressing 2.4in x2.4in
00361554005621Hydrogel Sheet Dressing 4.7"x3.4"
00361554005607Hydrogel Sheet Dressing 7"x5"
00361554005584Hydrogel Sheet Dressing 2.4"x 2.4"
15056860000065Hydrogel Sheet Dressing 2.4"x 2.4"
00361554005591Hydrogel Sheet Dressing 2.4"x 2.4"
00361554001128GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm)
00361554001098GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm)
00361554003375GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm)
00361554007182GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm)
00361554007250GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm)
00361554007229GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm)

Trademark Results [Gentell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENTELL
GENTELL
86160299 5532584 Live/Registered
Navazio, David
2014-01-08
GENTELL
GENTELL
74686333 1999426 Dead/Cancelled
Gentell, Inc.
1995-06-09

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