BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hintermann Series H3

    DI: B095300407 · Model: 1 · Dt Medtech, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Hintermann Series H3
    Primary DI
    B095300407
    Version / Model
    1
    Catalog Number
    300407
    Company Name
    Dt Medtech, LLC
    Labeler DUNS
    080101891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-19
    Public Version
    5
    Public Version Date
    2025-09-05
    Public Version Status
    Update
    Public Device Record Key
    240f343a-322b-496c-bbf7-ed5ada3c7889

    Device Description

    H3 PE INLAY SIZE 4- 7mm

    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
    No
    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
    NTG Prosthesis, Ankle, Uncemented, Non-Constrained

    GMDN Terms

    Code Name
    48180 Ankle prosthesis bearing

    Identifiers

    Type ID
    Primary B095300407

    Customer Contacts

    Phone
    800-521-5002
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P160036 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify SIZE 4 - 7mm