BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Site Prep Barbed Guide

    DI: 00850040139433 · Model: SR07-6020 · SURGENTEC, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Site Prep Barbed Guide
    Primary DI
    00850040139433
    Version / Model
    SR07-6020
    Company Name
    SURGENTEC, LLC
    Labeler DUNS
    004095409
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-03
    Public Version
    1
    Public Version Date
    2025-01-13
    Public Version Status
    New
    Public Device Record Key
    f7cc7fd1-6e99-4733-9f29-1c06e72f6e84

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    PDQ Neurosurgical Nerve Locator

    GMDN Terms

    Code Name
    16833 Bone marrow biopsy procedure kit

    Identifiers

    Type ID
    Primary 00850040139433

    Premarket Submissions

    Submission Number Supplement Number
    K240664 000