UNM Montage Flowable Dispenser

GUDID 00850391007344

ABYRX, INC.

Bone wax, synthetic

• Primary Device ID: 00850391007344
• NIH Device Record Key: ab5cdd7d-60aa-42eb-b712-fc23784bb4de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNM Montage Flowable Dispenser
• Version Model Number: 900-MFL
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850391007344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193052

FDA Product Code

• MTJ: Wax, Bone

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: 2022-09-02
• Device Publish Date: 2022-08-25

Devices Manufactured by ABYRX, INC.

• 00850391007450 - Permatage 10cc: 2025-05-29
• 00850391007443 - Abyrx Spatula Stand Alone: 2025-04-16
• 00850391007016 - Montage XT 5cc: 2025-04-15
• 00850391007436 - Montage CT 7cc: 2025-04-15
• 00850391007245 - Montage Settable Bone Putty: 2023-11-24
• 00850391007252 - Montage Settable Bone Putty: 2023-11-24
• 00850391007290 - Montage Flowable Settable Bone Paste: 2023-11-24 8cc Cartridge
• 00850391007306 - Montage Flowable Settable Bone Paste: 2023-11-24 Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable