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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MicroAire®

    DI: 00847399014665 · Model: ZR-032NS · Microaire Surgical Instruments LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MicroAire®
    Primary DI
    00847399014665
    Version / Model
    ZR-032NS
    Company Name
    Microaire Surgical Instruments LLC
    Labeler DUNS
    103056420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-17
    Public Version
    1
    Public Version Date
    2022-09-26
    Public Version Status
    New
    Public Device Record Key
    6400f91b-f184-4c6c-8b95-cefbd6bfaba6

    Device Description

    STERNUM SAW BLADE, 9.4mm X 34mm X 1mm

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    GES Blade, Scalpel

    GMDN Terms

    Code Name
    44632 Sternum saw blade, single-use

    Identifiers

    Type ID
    Primary 00847399014665

    Device Sizes

    Type Value Unit Text
    Width 9.4 Millimeter
    Length 34 Millimeter
    Device Size Text, specify Cutting Thickness: 1 mm