BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-implantable, needle guide, reusable

    DI: 05704916001445 · Model: UA1256 · Bk Medical ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Non-implantable, needle guide, reusable
    Primary DI
    05704916001445
    Version / Model
    UA1256
    Company Name
    Bk Medical ApS
    Labeler DUNS
    310093901
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-19
    Public Version
    3
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    01595078-07dc-4999-be76-c6202798cbb8

    Device Description

    Reusable Puncture Attachment

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Peracetic Acid", "Hydrogen Peroxide", "Chlorine Dioxide"]

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 05704916001445

    Customer Contacts

    Phone
    +4544528100
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K173569 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    -25 – 70 Degrees Celsius