BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anterior Cervical Interbody Fusion Device

    DI: 00840019908115 · Model: 45-05-06P · PRECISION SPINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anterior Cervical Interbody Fusion Device
    Primary DI
    00840019908115
    Version / Model
    45-05-06P
    Catalog Number
    45-05-06P
    Company Name
    PRECISION SPINE, INC.
    Labeler DUNS
    079398589
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-12
    Public Version
    2
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    acc5345b-b7a6-4628-8085-57cf1540ecbc

    Device Description

    ACIF-Wide 5 degree 6mm

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00840019908115

    Premarket Submissions

    Submission Number Supplement Number
    K083118 000