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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Buxton BioMedical

    DI: B7689188290 · Model: 91-8829 · Buxton Biomedical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Buxton BioMedical
    Primary DI
    B7689188290
    Version / Model
    91-8829
    Catalog Number
    91.8829
    Company Name
    Buxton Biomedical Inc
    Labeler DUNS
    808385207
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-07
    Public Version
    1
    Public Version Date
    2023-07-17
    Public Version Status
    New
    Public Device Record Key
    38d4412a-5fcf-4d43-81f6-25d0745b4193

    Device Description

    Gelpi Guards, vnt, (45) 51mm

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXZ Guard, Instrument

    GMDN Terms

    Code Name
    63247 Surgical instrument guard, single-use

    Identifiers

    Type ID
    Primary B7689188290