BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00763000913489 · Model: 0363 · MEDTRONIC XOMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    N/A
    Primary DI
    00763000913489
    Version / Model
    0363
    Company Name
    MEDTRONIC XOMED, INC.
    Labeler DUNS
    835465063
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-23
    Public Version
    1
    Public Version Date
    2025-07-01
    Public Version Status
    New
    Public Device Record Key
    959ee0df-f4aa-4257-860a-d3380ab01521

    Device Description

    PROSTHESIS 0363 H/A NOTCHED OFFSET TOTAL

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ETA REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

    GMDN Terms

    Code Name
    35674 Ossicular prosthesis, total

    Identifiers

    Type ID
    Primary 00763000913489

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K885201 000