BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Montage Flowable Settable Bone Paste

    DI: 00850391007313 · Model: MON-BVF-1501FL · ABYRX, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Montage Flowable Settable Bone Paste
    Primary DI
    00850391007313
    Version / Model
    MON-BVF-1501FL
    Company Name
    ABYRX, INC.
    Labeler DUNS
    078818942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-16
    Public Version
    1
    Public Version Date
    2023-11-24
    Public Version Status
    New
    Public Device Record Key
    c5f467a8-a470-42ff-b538-8cb894cd9e31

    Device Description

    3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQV Filler, Bone Void, Calcium Compound
    OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

    GMDN Terms

    Code Name
    35809 Orthopaedic cement dispenser

    Identifiers

    Type ID
    Primary 00850391007313