BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OT-F2 / OT-F3 Prosthetics

    DI: EOTM0243890420101 · Model: 02-4389042010 · OT medical GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OT-F2 / OT-F3 Prosthetics
    Primary DI
    EOTM0243890420101
    Version / Model
    02-4389042010
    Catalog Number
    02-4389042010
    Company Name
    OT medical GmbH
    Labeler DUNS
    340998796
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    08110a92-433b-4970-aec5-b2735fdd7c9a

    Device Description

    ProfiLine, Bar Adapter, made by Titanium, Diameter: 3,8mm, Gingival height: 4,0 mm

    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
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary EOTM0243890420101