BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biomet® Hip System

    DI: 00887868308901 · Model: 163625 · Biomet Orthopedics, LLC
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Biomet® Hip System
    Primary DI
    00887868308901
    Version / Model
    163625
    Catalog Number
    163625
    Company Name
    Biomet Orthopedics, LLC
    Labeler DUNS
    129278169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-15
    Public Version
    2
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    3931663e-6759-4118-976b-4fb6be306615

    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
    KRO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
    JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
    LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    GMDN Terms

    Code Name
    43167 Acetabular shell

    Identifiers

    Type ID
    Primary 00887868308901

    Customer Contacts

    Phone
    +1(800)348-9500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K974558 000
    K984408 000
    K990830 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 26mm Ø Type1 Taper