Montage Settable Bone Putty

GUDID 00850391007252

ABYRX, INC.

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00850391007252
• NIH Device Record Key: 15d63839-3b80-4f72-8947-726c994daf70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montage Settable Bone Putty
• Version Model Number: MON-BVF-1604
• Company DUNS: 078818942
• Company Name: ABYRX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850391007252 [Primary]

FDA Product Code

• GXP: Methyl Methacrylate For Cranioplasty

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: 2023-11-24
• Device Publish Date: 2023-11-16

On-Brand Devices [Montage Settable Bone Putty]

• 00850391007252: MON-BVF-1604
• 00850391007245: MON-BVF-1001