BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Silk Lite Partial

    DI: 00643293032763 · Model: 538 03 · TRULIFE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Silk Lite Partial
    Primary DI
    00643293032763
    Version / Model
    538 03
    Company Name
    TRULIFE LIMITED
    Labeler DUNS
    985048669
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-26
    Public Version
    1
    Public Version Date
    2024-08-05
    Public Version Status
    New
    Public Device Record Key
    68881870-a6cc-4d38-b3bd-b89aa0992fc4

    Device Description

    Triangle Silk Lite Partial Beige 3

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOJ PROSTHESIS, BREAST, EXTERNAL, NO ADHESIVE

    GMDN Terms

    Code Name
    35676 External breast prosthesis

    Identifiers

    Type ID
    Primary 00643293032763