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

• 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