DirectCell Advanced Bone Grafting System BGS-8C-012-AGL

GUDID 00812593020590

Kit Contains: (1) 012-AGL, 12cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

BIOGENNIX LLC

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 00812593020590
• NIH Device Record Key: 9f426797-cc28-4ed5-bfa5-ec800c245404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectCell Advanced Bone Grafting System
• Version Model Number: BGS-8C-012-AGL
• Catalog Number: BGS-8C-012-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	00812593020590 [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