BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: 00304040005019 · Model: 1127132 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Henry Schein
    Primary DI
    00304040005019
    Version / Model
    1127132
    Catalog Number
    1127132
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2e8d0f64-3ceb-4e4c-8b93-bf606cbac38c

    Device Description

    Essential Curing Light Sleeve

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PEM Dental barriers and sleeves

    GMDN Terms

    Code Name
    61049 Instrument/equipment drape, single-use, non-sterile

    Identifiers

    Type ID
    Package 10304040005016
    Primary 00304040005019
    Unit of Use 20304040005013