BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sensor Boot Set

    DI: 00852184003786 · Model: 22-3010-00 · Synapse Biomedical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sensor Boot Set
    Primary DI
    00852184003786
    Version / Model
    22-3010-00
    Company Name
    Synapse Biomedical, Inc.
    Labeler DUNS
    138432070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-31
    Public Version
    1
    Public Version Date
    2025-11-10
    Public Version Status
    New
    Public Device Record Key
    5e970469-eb52-4793-aec1-ef14c23f19c3

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GZI Stimulator, Neuromuscular, External Functional

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00852184003786

    Customer Contacts

    Phone
    1-888-767-3770
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K242704 000