BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Protean

    DI: 00841506137193 · Model: PROTEAN Fragment Plate, Ladder, 1.5 · SKELETAL DYNAMICS L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Protean
    Primary DI
    00841506137193
    Version / Model
    PROTEAN Fragment Plate, Ladder, 1.5
    Catalog Number
    PRT-LDR-015
    Company Name
    SKELETAL DYNAMICS L.L.C.
    Labeler DUNS
    869056148
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-01
    Public Version
    1
    Public Version Date
    2025-12-09
    Public Version Status
    New
    Public Device Record Key
    5cd2f860-188a-43c4-a56c-53fe6db2f0b1

    Device Description

    PROTEAN Fragment Plate, Ladder, 1.5

    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
    Yes
    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
    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
    HRS Plate, fixation, bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00841506137193

    Customer Contacts

    Phone
    +1(305)596-7585
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K241815 000