Agilon Surgical Matrix

GUDID 00812593022037

Agilon Surgical Matrix 2mL

Biogennix, LLC

Collagen wound matrix dressing
Primary Device ID00812593022037
NIH Device Record Keyf7ea9f3a-d990-474a-8b2f-847f39423636
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgilon Surgical Matrix
Version Model NumberASM-015
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
GS100812593022037 [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 Date2025-05-30
Device Publish Date2025-05-22

On-Brand Devices [Agilon Surgical Matrix]

00812593021771ASM-030
00812593022037Agilon Surgical Matrix 2mL

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