BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Critigear

    DI: 10810012921012 · Model: HCGS0002 · CONTEC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Critigear
    Primary DI
    10810012921012
    Version / Model
    HCGS0002
    Company Name
    CONTEC, INC.
    Labeler DUNS
    197223357
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-01-31
    Public Version
    1
    Public Version Date
    2020-02-10
    Public Version Status
    New
    Public Device Record Key
    96b229bd-4b6a-44fe-bc68-be840ab6f329

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove
    LZC Patient Examination Glove, Specialty

    GMDN Terms

    Code Name
    61631 Nitrile examination/treatment glove, non-powdered, sterile

    Identifiers

    Type ID
    Package 20810012921019
    Primary 10810012921012
    Unit of Use 00810012921015