BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Torque Wrench EV Restorative Driver Handle 4 ×4 Low

    DI: 05712821000057 · Model: 25730 · Elos Medtech Pinol A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Torque Wrench EV Restorative Driver Handle 4 ×4 Low
    Primary DI
    05712821000057
    Version / Model
    25730
    Company Name
    Elos Medtech Pinol A/S
    Labeler DUNS
    306155953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-31
    Public Version
    2
    Public Version Date
    2022-08-31
    Public Version Status
    Update
    Public Device Record Key
    5fbe892e-5c5c-408a-9252-84d768d37c25

    Device Description

    A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.

    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
    61946 Surgical torque wrench adaptor

    Identifiers

    Type ID
    Primary 05712821000057
    Direct Marking 05712821009357