BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PragmaTool

    DI: 06972884983035 · Model: 801961500 · Hangzhou Rejoin Mastin Medical Device Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PragmaTool
    Primary DI
    06972884983035
    Version / Model
    801961500
    Company Name
    Hangzhou Rejoin Mastin Medical Device Co., Ltd.
    Labeler DUNS
    560430218
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-22
    Public Version
    1
    Public Version Date
    2023-05-30
    Public Version Status
    New
    Public Device Record Key
    9005a6ca-7dc9-4e95-a0ce-ab589cd2c135

    Device Description

    Retrograde Reamer, Tibia, 7.0mm, S

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

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

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44091 Arthroscopic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 06972884983035