BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OT EQUATOR-OT BRIDGE

    DI: D821130RPS435 · Model: OT EQUATOR ReplaceSelect ø 4,3 h.5 · RHEIN 83 SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OT EQUATOR-OT BRIDGE
    Primary DI
    D821130RPS435
    Version / Model
    OT EQUATOR ReplaceSelect ø 4,3 h.5
    Catalog Number
    130RPS435
    Company Name
    RHEIN 83 SRL
    Labeler DUNS
    439240722
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-18
    Public Version
    2
    Public Version Date
    2021-01-28
    Public Version Status
    Update
    Public Device Record Key
    70bf6492-55bd-4dae-8397-7a161619772a
    Distribution End Date
    2021-01-27

    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    47829 Surgical instrument handle, non-torque-limiting

    Identifiers

    Type ID
    Primary D821130RPS435