BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reform POCT System

    DI: 00840019927062 · Model: 55-SC-0305 · PRECISION SPINE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Reform POCT System
    Primary DI
    00840019927062
    Version / Model
    55-SC-0305
    Catalog Number
    55-SC-0305
    Company Name
    PRECISION SPINE, INC.
    Labeler DUNS
    079398589
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-27
    Public Version
    1
    Public Version Date
    2019-04-04
    Public Version Status
    New
    Public Device Record Key
    5e2e319c-338e-4b70-b60a-03b8f6412db5

    Device Description

    Ø4.5mm Polyaxial Screw Caddy

    Device Characteristics

    Single Use
    No
    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
    NKG Orthosis, Cervical Pedicle Screw Spinal Fixation
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00840019927062

    Premarket Submissions

    Submission Number Supplement Number
    K162300 000
    K172495 000