BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Genius Concentration System

    DI: M263G00001K0 · Model: 64002-09 · DSM BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Genius Concentration System
    Primary DI
    M263G00001K0
    Version / Model
    64002-09
    Catalog Number
    G00001
    Company Name
    DSM BIOMEDICAL, INC.
    Labeler DUNS
    131107757
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-22
    Public Version
    6
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    a89d1441-8107-4a08-be81-a8b4ee28884e
    Distribution End Date
    2023-03-10

    Device Description

    Centrifuge

    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
    No
    Has Serial Number
    Yes
    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
    ORG Platelet And Plasma Separator For Bone Graft Handling

    GMDN Terms

    Code Name
    47154 Haematological concentrate system centrifuge

    Identifiers

    Type ID
    Direct Marking M263G000010
    Primary M263G00001K0