BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    8.0 MHz Sterilizable Superficial Vascular Probe

    DI: 00888937001396 · Model: TSP-8S · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    8.0 MHz Sterilizable Superficial Vascular Probe
    Primary DI
    00888937001396
    Version / Model
    TSP-8S
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-31
    Public Version
    6
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    edd732e7-c04e-4f7d-8741-2324a31990e8

    Device Description

    For TRIA II Dopplers

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    HEP Monitor, Blood-Flow, Ultrasonic

    GMDN Terms

    Code Name
    36970 Noninvasive vascular ultrasound system probe

    Identifiers

    Type ID
    Primary 00888937001396

    Premarket Submissions

    Submission Number Supplement Number
    K024197 000