Collagen Dressings XXX

GUDID 10361554000722

Gentell, LLC

Collagen wound matrix dressing
Primary Device ID10361554000722
NIH Device Record Key33aaad13-3460-418c-ae44-20428502a190
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollagen Dressings
Version Model NumberXXXX
Catalog NumberXXX
Company DUNS170967876
Company NameGentell, LLC
Device Count300
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
GS110361554000722 [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 Date2024-07-16
Device Publish Date2024-07-08

Devices Manufactured by Gentell, LLC

00361554000084 - Collagen Particles2024-08-23 Collagen Particles Wound Filler 1gram pouch
10361554002047 - Gentell2024-07-22
10361554000081 - Gentell2024-07-16
10361554000135 - Gentell2024-07-16 Collagen wound dressings 7"x7"
10361554000722 - Collagen Dressings2024-07-16
10361554000722 - Collagen Dressings2024-07-16
10361554003051 - Gentell2024-07-16
20361554000088 - Gentell2024-07-16
00361554000787 - Gentell2024-07-10 Collagen Particles Wound Filler 1 gram Pouch

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.