BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Electrode Delivery Tool

    DI: 00852184003588 · Model: 21-0039-99 · Synapse Biomedical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Electrode Delivery Tool
    Primary DI
    00852184003588
    Version / Model
    21-0039-99
    Company Name
    Synapse Biomedical, Inc.
    Labeler DUNS
    138432070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-16
    Public Version
    1
    Public Version Date
    2021-03-24
    Public Version Status
    New
    Public Device Record Key
    f8095f9f-c18b-41de-a343-f5a68afc7639

    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
    No
    Has Serial Number
    Yes
    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
    OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    GMDN Terms

    Code Name
    47808 Intramuscular diaphragm/phrenic nerve electrical stimulation system

    Identifiers

    Type ID
    Primary 00852184003588