BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ShurFit Interbody Device

    DI: 00840019909679 · Model: PLIF22-14P · PRECISION SPINE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ShurFit Interbody Device
    Primary DI
    00840019909679
    Version / Model
    PLIF22-14P
    Catalog Number
    PLIF22-14P
    Company Name
    PRECISION SPINE, INC.
    Labeler DUNS
    079398589
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-16
    Public Version
    2
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    ede07363-1f15-4e81-81fd-07572afcc424

    Device Description

    PLIF Cage Peek 14mm x 22mm

    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00840019909679

    Premarket Submissions

    Submission Number Supplement Number
    K092193 000