BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TZ Medical Pressure Discs

    DI: 10811331010487 · Model: 8880-04 · Tz Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    TZ Medical Pressure Discs
    Primary DI
    10811331010487
    Version / Model
    8880-04
    Company Name
    Tz Medical, Inc.
    Labeler DUNS
    793149709
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    674beb5f-9a51-40c6-861e-efd9a0073b4e

    Device Description

    Round Universal Disc w/ Omega opening

    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
    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
    DXC Clamp, Vascular

    GMDN Terms

    Code Name
    47927 Femoral artery compression system, manual, single-use

    Identifiers

    Type ID
    Unit of Use 00811331010480
    Primary 10811331010487

    Premarket Submissions

    Submission Number Supplement Number
    K914149 000