BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGISTAR

    DI: 00878799001061 · Model: 5591 · SURGISTAR, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    SURGISTAR
    Primary DI
    00878799001061
    Version / Model
    5591
    Company Name
    SURGISTAR, INC.
    Labeler DUNS
    808865125
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-01
    Public Version
    5
    Public Version Date
    2021-01-22
    Public Version Status
    Update
    Public Device Record Key
    79f999e5-d51a-4c74-974b-2d05eeef25b7

    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
    GDX Scalpel, One-Piece

    GMDN Terms

    Code Name
    37445 Manual scalpel blade, single-use

    Identifiers

    Type ID
    Package 10878799001068
    Primary 00878799001061

    Customer Contacts

    Phone
    17605982480
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923689 000