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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROTO SILENTA 630 RS

    DI: 04050674031141 · Model: ROTO SILENTA 630 RS STANDARD · Andreas Hettich GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ROTO SILENTA 630 RS
    Primary DI
    04050674031141
    Version / Model
    ROTO SILENTA 630 RS STANDARD
    Catalog Number
    5005-08
    Company Name
    Andreas Hettich GmbH & Co. KG
    Labeler DUNS
    316403245
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-02
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    83958759-9e24-4f37-9134-e2b078d1b46c

    Device Description

    Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate

    Device Characteristics

    Single Use
    No
    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
    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
    JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

    GMDN Terms

    Code Name
    15115 Blood bank centrifuge

    Identifiers

    Type ID
    Primary 04050674031141