BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ankle Toe Cap SatPad™

    DI: 00850004813072 · Model: 1 · Sat Pad Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ankle Toe Cap SatPad™
    Primary DI
    00850004813072
    Version / Model
    1
    Catalog Number
    100007
    Company Name
    Sat Pad Inc.
    Labeler DUNS
    081347868
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-02
    Public Version
    2
    Public Version Date
    2019-04-12
    Public Version Status
    Update
    Public Device Record Key
    fce9e868-0c65-4038-88fa-7df396399c5f

    Device Description

    Ankle Toe Cap Radiological Positioning Device For MR

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LNH System, Nuclear Magnetic Resonance Imaging

    GMDN Terms

    Code Name
    40900 Radiological arm/leg positioner

    Identifiers

    Type ID
    Primary 00850004813072
    Package 10850004813079

    Customer Contacts

    Phone
    667-225-2721
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K926416 000