BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rex Mallet

    DI: D894045700121010 · Model: P. Striker/Remover · Rex Implants, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rex Mallet
    Primary DI
    D894045700121010
    Version / Model
    P. Striker/Remover
    Catalog Number
    04570012-101
    Company Name
    Rex Implants, Inc.
    Labeler DUNS
    080746478
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-07
    Public Version
    4
    Public Version Date
    2026-02-09
    Public Version Status
    Update
    Public Device Record Key
    26d90693-0b61-4ce2-a47f-714f43e678ed

    Device Description

    Posterior Striker/Remover

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    GEY Motor, Surgical Instrument, Ac-Powered

    GMDN Terms

    Code Name
    32856 Orthopaedic implant impactor, reusable

    Identifiers

    Type ID
    Primary D894045700121010

    Customer Contacts

    Phone
    6146538429
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 70 Degrees Celsius