BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MANZA POLYETHYLENE LINER

    DI: 00841176100855 · Model: 102-01-030 · STINSON ORTHOPEDICS INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MANZA POLYETHYLENE LINER
    Primary DI
    00841176100855
    Version / Model
    102-01-030
    Catalog Number
    102-01-030
    Company Name
    STINSON ORTHOPEDICS INC.
    Labeler DUNS
    080460688
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-26
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    06814ad8-768c-4b27-a600-7c36022bfc34

    Device Description

    MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 B 10 DEGREE

    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
    Yes
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

    GMDN Terms

    Code Name
    43168 Non-constrained polyethylene acetabular liner

    Identifiers

    Type ID
    Primary 00841176100855

    Premarket Submissions

    Submission Number Supplement Number
    K121297 000