BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Phadia Prime

    DI: 07333066015101 · Model: 12-4101-00 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Phadia Prime
    Primary DI
    07333066015101
    Version / Model
    12-4101-00
    Catalog Number
    12-4101-00
    Company Name
    Phadia AB
    Labeler DUNS
    354019424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-14
    Public Version
    4
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    10f2a0e3-ab8e-4745-96a5-6572b58be25a

    Device Description

    Phadia Prime

    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
    No
    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
    DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 07333066015101

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K151029 000