BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InSight 2

    DI: 15420045505896 · Model: InSight 2 · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InSight 2
    Primary DI
    15420045505896
    Version / Model
    InSight 2
    Company Name
    Hologic, Inc.
    Labeler DUNS
    153623137
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    4
    Public Version Date
    2022-10-05
    Public Version Status
    Update
    Public Device Record Key
    092327e4-55a0-4c2c-837d-e3f0205ace46

    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
    MR Unsafe
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAA System, x-ray, fluoroscopic, image-intensified

    GMDN Terms

    Code Name
    37649 Portable general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 15420045505896

    Premarket Submissions

    Submission Number Supplement Number
    K051025 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    16 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius