BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sentosa ST401e

    DI: 08885013950076 · Model: 400120 · VELA OPERATIONS SINGAPORE PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sentosa ST401e
    Primary DI
    08885013950076
    Version / Model
    400120
    Catalog Number
    400120
    Company Name
    VELA OPERATIONS SINGAPORE PTE. LTD.
    Labeler DUNS
    595361724
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-19
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    6df77f47-4380-4889-932a-b4b1704bdf22

    Device Description

    ST401e is used for enrichment and forms part of SQ301 Platform.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    PFF High Throughput Dna Sequence Analyzer

    GMDN Terms

    Code Name
    35477 Clinical laboratory information system

    Identifiers

    Type ID
    Primary 08885013950076