Agilon Surgical Matrix

GUDID 00812593021771

Biogennix, LLC

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00812593021771
• NIH Device Record Key: 915797ca-c63b-4c10-801f-61adedf897a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agilon Surgical Matrix
• Version Model Number: ASM-030
• Company DUNS: 832270370
• Company Name: Biogennix, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593021764 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	00812593021771 [Primary]

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-01
• Device Publish Date: 2024-03-22

Devices Manufactured by Biogennix, LLC

• 00812593021771 - Agilon Surgical Matrix: 2024-04-01
• 00812593021771 - Agilon Surgical Matrix: 2024-04-01
• 00812593021689 - PURvital: 2024-03-18
• 00812593021696 - PURvital: 2024-03-18
• 00812593021702 - PURvital: 2024-03-18
• 00812593021719 - PURvital: 2024-03-18
• 00812593021580 - ossFX: 2023-12-21 ossFX Fusion Kit
• 00812593021597 - ossFX: 2023-12-21 ossFX 3cc
• 00812593021603 - ossFX: 2023-12-21 ossFX 6cc