Collagen Particles xxx

GUDID 00361554000084

Collagen Particles Wound Filler 1gram pouch

Gentell, LLC

Collagen wound matrix dressing
Primary Device ID00361554000084
NIH Device Record Key0ab9de80-08dd-4d8b-bf60-80df61562da1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollagen Particles
Version Model Numberxxxx
Catalog Numberxxx
Company DUNS170967876
Company NameGentell, LLC
Device Count50
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
GS100361554000084 [Primary]
GS110361554000777 [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 Date2024-08-23
Device Publish Date2024-08-15

Devices Manufactured by Gentell, LLC

00361554003733 - Gentell2024-12-09 Honey Hydrogel Dressing 2.4in x2.4in
00361554003764 - Gentell2024-12-09 Honey Hydrogel Dressing 4.7in x3.4in
00361554003771 - Gentell2024-12-09 Honey Hydrogel Dressing 7in x5in
00361554003818 - Gentell2024-12-09 Silicone Bordered Gauze 4in x 4in
00361554003856 - Gentell2024-12-09 Silicone Bordered Gauze 6inx6in
00361554003863 - Gentell2024-12-09 Silicone Bordered gauze 8inx8in
00361554000084 - Collagen Particles2024-08-23Collagen Particles Wound Filler 1gram pouch
00361554000084 - Collagen Particles2024-08-23 Collagen Particles Wound Filler 1gram pouch
10361554002047 - Gentell2024-07-22

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