BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PROMIX one

    DI: J00927700010000 · Model: 2770001000 · Renfert GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PROMIX one
    Primary DI
    J00927700010000
    Version / Model
    2770001000
    Catalog Number
    2770001000
    Company Name
    Renfert GmbH
    Labeler DUNS
    328502976
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-10
    Public Version
    1
    Public Version Date
    2023-07-18
    Public Version Status
    New
    Public Device Record Key
    2921d914-5088-422a-b00c-748cb7c92694

    Device Description

    Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    EFD Amalgamator, Dental, Ac-Powered

    GMDN Terms

    Code Name
    10082 Dental amalgam mixer

    Identifiers

    Type ID
    Primary J00927700010000

    Storage Conditions

    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 105 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 96 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit