BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acumatch L-Series

    DI: 10885862011992 · Model: 102-20-53 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acumatch L-Series
    Primary DI
    10885862011992
    Version / Model
    102-20-53
    Catalog Number
    102-20-53
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-30
    Public Version
    4
    Public Version Date
    2020-04-06
    Public Version Status
    Update
    Public Device Record Key
    4674a4b8-376f-431e-ad0b-386ca1b39f5e

    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

    GMDN Terms

    Code Name
    33175 Metallic femoral head prosthesis

    Identifiers

    Type ID
    Primary 10885862011992

    Premarket Submissions

    Submission Number Supplement Number
    K010081 000

    Device Sizes

    Type Value Unit Text
    Outer Diameter 53 Millimeter