Agilon Surgical Matrix

GUDID 00812593021771

Biogennix, LLC

Collagen wound matrix dressing
Primary Device ID00812593021771
NIH Device Record Key915797ca-c63b-4c10-801f-61adedf897a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgilon Surgical Matrix
Version Model NumberASM-030
Company DUNS832270370
Company NameBiogennix, LLC
Device Count1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812593021764 [Package]
Package: Case [12 Units]
In Commercial Distribution
GS100812593021771 [Primary]

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 Date2024-04-01
Device Publish Date2024-03-22

Devices Manufactured by Biogennix, LLC

00812593022273 - ossFX Surgical Matrix2024-11-27
00812593021726 - bYomed Surgical MatriX2024-11-13
00812593021818 - NeoForm CWM2024-06-13
00812593021771 - Agilon Surgical Matrix2024-04-01
00812593021771 - Agilon Surgical Matrix2024-04-01
00812593021689 - PURvital2024-03-18
00812593021696 - PURvital2024-03-18
00812593021702 - PURvital2024-03-18
00812593021719 - PURvital2024-03-18

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