BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HYGITECH

    DI: 03615140002561 · Model: HY-130012 · HYGITECH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HYGITECH
    Primary DI
    03615140002561
    Version / Model
    HY-130012
    Catalog Number
    HY-130012
    Company Name
    HYGITECH
    Labeler DUNS
    279456896
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-24
    Public Version
    4
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    6defeaf5-367b-4441-aac6-6b12e0d4d825

    Device Description

    Ideal for short procedures or simple patient visits. Packed in a transparent plastic peel pack tray, which provides easy identification of contents. Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDD Kit, Surgical Instrument, Disposable

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Package 03615140002578
    Primary 03615140002561
    Package 03615140002585