DirectCell Advanced Bone Grafting System BGS-8C-010-AGS

GUDID 00812593021542

Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution 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

• Primary Device ID: 00812593021542
• NIH Device Record Key: a4b000d7-4d6c-4665-b105-d1b71883437c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectCell Advanced Bone Grafting System
• Version Model Number: BGS-8C-010-AGS
• Catalog Number: BGS-8C-010-AGS
• 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: 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593021542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190177

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: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [DirectCell Advanced Bone Grafting System]

• 00812593021559: Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellu
• 00812593021542: Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cell
• 00812593021573: Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCel