BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Criterion CL Glove PF Latex

    DI: 10304040110048 · Model: 1025357 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Criterion CL Glove PF Latex
    Primary DI
    10304040110048
    Version / Model
    1025357
    Catalog Number
    1025357
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2020-01-08
    Public Version
    2
    Public Version Date
    2020-06-19
    Public Version Status
    Update
    Public Device Record Key
    dd314a69-cc3e-4456-8f29-55ad498491a7

    Device Description

    Criterion CL Glove PF Latex X-Large

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LYY Latex patient examination glove

    GMDN Terms

    Code Name
    47172 Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Package 20304040110045
    Primary 10304040110048
    Unit of Use 00304040110041

    Premarket Submissions

    Submission Number Supplement Number
    K981917 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    FALSE