BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Truliant, Activit-E

    DI: 10885862596383 · Model: 02-023-02-0032 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Truliant, Activit-E
    Primary DI
    10885862596383
    Version / Model
    02-023-02-0032
    Catalog Number
    02-023-02-0032
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-12
    Public Version
    1
    Public Version Date
    2023-09-20
    Public Version Status
    New
    Public Device Record Key
    cb5cc7a7-36e2-4ab8-996b-dc3f16dd93b9

    Device Description

    PATELLA

    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
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
    OIY Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

    GMDN Terms

    Code Name
    34199 Polyethylene patella prosthesis

    Identifiers

    Type ID
    Primary 10885862596383

    Premarket Submissions

    Submission Number Supplement Number
    K223252 000