BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PMT CORPORATION - STEREOTACTIC

    DI: 00650551147008 · Model: 2103-195 · PMT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PMT CORPORATION - STEREOTACTIC
    Primary DI
    00650551147008
    Version / Model
    2103-195
    Company Name
    PMT CORPORATION
    Labeler DUNS
    039576871
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-12
    Public Version
    1
    Public Version Date
    2021-07-20
    Public Version Status
    New
    Public Device Record Key
    c6ba154d-d7a6-49e5-a15a-1ab0a0e4960d

    Device Description

    REDUCING TUBE FOR 3.2MM DRILL - NEUROMATE

    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
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 00650551147008

    Premarket Submissions

    Submission Number Supplement Number
    K831329 000