Gentell xxxx

GUDID 10361554002047

Gentell, LLC

Collagen wound matrix dressing
Primary Device ID10361554002047
NIH Device Record Key333125f4-73f3-4cae-a468-154cd6ee7345
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentell
Version Model Numberxxxx
Catalog Numberxxxx
Company DUNS170967876
Company NameGentell, LLC
Device Count30
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com
Phone6474088343
Emailsri.divya@gentell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110361554002047 [Primary]
GS110361554003143 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-13

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

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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