BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SleeperOne 5

    DI: 03760349803331 · Model: SO_5C · DENTALHITEC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SleeperOne 5
    Primary DI
    03760349803331
    Version / Model
    SO_5C
    Catalog Number
    SO-5C
    Company Name
    DENTALHITEC
    Labeler DUNS
    640616736
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-22
    Public Version
    1
    Public Version Date
    2023-08-30
    Public Version Status
    New
    Public Device Record Key
    47cb199b-b679-45a4-84ff-dd04116f3eb6

    Device Description

    1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EJI Syringe, Cartridge

    GMDN Terms

    Code Name
    60599 Dental computer assisted anaesthesia injection unit

    Identifiers

    Type ID
    Direct Marking 03760349809913
    Primary 03760349803331