BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Encompass 15 Channel MRI Head Coil - 1,5T

    DI: 04251269204685 · Model: 01 · Noras MRI products GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Encompass 15 Channel MRI Head Coil - 1,5T
    Primary DI
    04251269204685
    Version / Model
    01
    Catalog Number
    119890
    Company Name
    Noras MRI products GmbH
    Labeler DUNS
    312844095
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-15
    Public Version
    2
    Public Version Date
    2020-03-05
    Public Version Status
    Update
    Public Device Record Key
    ee34ec14-b76e-4d31-87b6-b1e9abe663b3

    Device Description

    Head Coil

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    MOS Coil, Magnetic Resonance, Specialty
    HBL Holder, Head, Neurosurgical (Skull Clamp)

    GMDN Terms

    Code Name
    40749 MRI system coil, radio-frequency

    Identifiers

    Type ID
    Primary 04251269204685

    Customer Contacts

    Phone
    +49931299270
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K190668 000