BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HYPE SCL

    DI: 03662200025794 · Model: HYPE SCL 3 · SOC ETUDES RECHERCHES FABRICATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HYPE SCL
    Primary DI
    03662200025794
    Version / Model
    HYPE SCL 3
    Company Name
    SOC ETUDES RECHERCHES FABRICATION
    Labeler DUNS
    282651413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-29
    Public Version
    1
    Public Version Date
    2024-02-06
    Public Version Status
    New
    Public Device Record Key
    dacd8ca3-f965-462a-9e43-21a4f5f06dbd

    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
    MR Conditional
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

    GMDN Terms

    Code Name
    38155 Press-fit femoral stem prosthesis

    Identifiers

    Type ID
    Primary 03662200025794