BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Initia Total Hip System

    DI: 04547898306068 · Model: GMH02-200047 · KYOCERA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Initia Total Hip System
    Primary DI
    04547898306068
    Version / Model
    GMH02-200047
    Catalog Number
    GMH02-200047
    Company Name
    KYOCERA CORPORATION
    Labeler DUNS
    690557624
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-21
    Public Version
    4
    Public Version Date
    2020-05-21
    Public Version Status
    Update
    Public Device Record Key
    ad74529e-c334-44fa-bee9-89ab4361101c

    Device Description

    STD LINER 26-46

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    GMDN Terms

    Code Name
    33181 Metal-on-polyethylene total hip prosthesis

    Identifiers

    Type ID
    Primary 04547898306068

    Customer Contacts

    Phone
    909-557-2360
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 46mm O.D.
    Device Size Text, specify 26mm I.D.
    Device Size Text, specify Type:Flat
    Device Size Text, specify Size:26-46