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    FDA UDI In Commercial Distribution 🇺🇸 United States

    OT-F2 Implant

    DI: EOTM0213421600101 · Model: 02-1342160010 · OT medical GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OT-F2 Implant
    Primary DI
    EOTM0213421600101
    Version / Model
    02-1342160010
    Catalog Number
    02-1342160010
    Company Name
    OT medical GmbH
    Labeler DUNS
    340998796
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    80b5789d-d292-41d0-86c5-107cb854555c

    Device Description

    Dental Implant, Screw, made by Titanium, Diameter: 3,4 mm, Length: 16 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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary EOTM0213421600101