BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUICKSLEEPER 5C_A2 US/CA

    DI: 03760349801054 · Model: QS_5C_A2 · DENTALHITEC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUICKSLEEPER 5C_A2 US/CA
    Primary DI
    03760349801054
    Version / Model
    QS_5C_A2
    Catalog Number
    QS_5C_A2
    Company Name
    DENTALHITEC
    Labeler DUNS
    640616736
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-22
    Public Version
    1
    Public Version Date
    2025-12-30
    Public Version Status
    New
    Public Device Record Key
    bd9fc04c-7f3d-4eea-b2c4-f77e6d3924cd

    Device Description

    1 QuickSleeper 5 handpiece and control box 1 wireless pedal 1 power cable 1 power supply, 6 containers 1 user manual 1 box of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) 1 box of dental needles C3029 (primary DI Number: 03760349800514)

    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
    No
    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
    EGM Injector, Jet, Mechanical-Powered
    EJI Syringe, Cartridge

    GMDN Terms

    Code Name
    60599 Dental computer assisted anaesthesia injection unit

    Identifiers

    Type ID
    Primary 03760349801054
    Direct Marking 03760349809715