BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    13G Tuohy Needle 4.5"

    DI: 00859619004967 · Model: MD0505-A · STIMWAVE TECHNOLOGIES INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    13G Tuohy Needle 4.5"
    Primary DI
    00859619004967
    Version / Model
    MD0505-A
    Company Name
    STIMWAVE TECHNOLOGIES INCORPORATED
    Labeler DUNS
    078294927
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-25
    Public Version
    1
    Public Version Date
    2018-11-26
    Public Version Status
    New
    Public Device Record Key
    1824b35a-f19c-493b-802c-f439753c149d

    Device Description

    13G Tuohy Needle 4.5"

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    Yes
    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
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

    GMDN Terms

    Code Name
    44063 Neurosurgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00859619004967

    Premarket Submissions

    Submission Number Supplement Number
    K180981 000

    Device Sizes

    Type Value Unit Text
    Length 11.43 Centimeter
    Length 4.5 Inch

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -29 – 60 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 140 Degrees Fahrenheit