DirectCell Advanced Bone Grafting System BGS-8C-003-AGL

GUDID 00812593020576

Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

BIOGENNIX LLC

Synthetic bone graft

• Primary Device ID: 00812593020576
• NIH Device Record Key: 03ce89fe-d858-4dc7-ae4b-e5883c9e1b75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectCell Advanced Bone Grafting System
• Version Model Number: BGS-8C-003-AGL
• Catalog Number: BGS-8C-003-AGL
• Company DUNS: 021486533
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020576 [Primary]

FDA Product Code

• KNW: Instrument, Biopsy

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: 2020-08-26
• Device Publish Date: 2020-08-18

On-Brand Devices [DirectCell Advanced Bone Grafting System]

• 00812593020590: Kit Contains: (1) 012-AGL, 12cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCell
• 00812593020583: Kit Contains: (1) 006-AGL, 6cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellu
• 00812593020576: Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellu
• 00812593020477: Kit Contains: (1) 012-MOR, 12cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution B
• 00812593020460: Kit Contains: (1) 006-MOR, 6cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bo
• 00812593020453: Kit Contains: (1) 003-MOR, 3cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bo