BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aveta Disposable Resecting Handset

    DI: 00850006759279 · Model: 213-060 · MEDITRINA, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aveta Disposable Resecting Handset
    Primary DI
    00850006759279
    Version / Model
    213-060
    Catalog Number
    213-060
    Company Name
    MEDITRINA, INC.
    Labeler DUNS
    080570262
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-10
    Public Version
    1
    Public Version Date
    2020-09-18
    Public Version Status
    New
    Public Device Record Key
    8c3be62b-8de0-4311-8604-f60936813ba2

    Device Description

    Aveta Disposable Resecting Handset for use with Aveta System

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIG Insufflator, Hysteroscopic
    HIH Hysteroscope (And Accessories)

    GMDN Terms

    Code Name
    46730 Tissue morcellation system control unit

    Identifiers

    Type ID
    Package 00850006759286
    Primary 00850006759279

    Premarket Submissions

    Submission Number Supplement Number
    K190372 000