Montage Flowable 8cc

GUDID 00850391007221

ABYRX, INC.

Bone wax, synthetic

• Primary Device ID: 00850391007221
• NIH Device Record Key: f4f09127-623b-4c89-9516-bf26e350af6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montage Flowable 8cc
• Version Model Number: OS-MON-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: 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	00850391007221 [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: 2021-02-22
• Device Publish Date: 2021-02-12

Devices Manufactured by ABYRX, INC.

• 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
• 00850391007313 - Montage Flowable Settable Bone Paste: 2023-11-24 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Fl
• 00850391007320 - Montage Flowable Settable Bone Paste: 2023-11-24 Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix
• 00850391007238 - Permatage 5cc: 2023-11-01
• 00850391007269 - Putty Applicator Gun: 2023-04-03