BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE

    DI: 00844505006972 · Model: 607 · Grace Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE
    Primary DI
    00844505006972
    Version / Model
    607
    Company Name
    Grace Medical, Inc.
    Labeler DUNS
    030849173
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-18
    Public Version
    4
    Public Version Date
    2021-10-04
    Public Version Status
    Update
    Public Device Record Key
    1fedecd1-3d36-4eeb-8ab6-dc69a3efdd6d
    Distribution End Date
    2021-04-06

    Device Description

    OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE - SIZERS INCLUDED TITANIUM/SILICONE

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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 00844505006972

    Customer Contacts

    Phone
    +1(866)472-2363
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K061853 000