Montage Flowable Settable Bone Paste

GUDID 00850391007306

Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable BVF Paste 00850391007290

ABYRX, INC.

Orthopaedic cement dispenser

• Primary Device ID: 00850391007306
• NIH Device Record Key: 77397886-de41-4270-8a86-ec43a9f6f296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montage Flowable Settable Bone Paste
• Version Model Number: MON-BVF-1501FL
• Company DUNS: 078818942
• Company Name: ABYRX, INC.
• 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: 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	00850391007306 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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 Flowable Settable Bone Paste]

• 00850391007320: Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 0085039100730
• 00850391007313: 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge
• 00850391007306: Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 0085
• 00850391007290: 8cc Cartridge