BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optical Front Pointer

    DI: B365503400 · Model: 50-340 · Aktina Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Optical Front Pointer
    Primary DI
    B365503400
    Version / Model
    50-340
    Company Name
    Aktina Corp.
    Labeler DUNS
    787178920
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    105d8cba-3d37-4253-8e8b-592d436f619e

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    38399 Accelerator system quality assurance device

    Identifiers

    Type ID
    Primary B365503400

    Premarket Submissions

    Submission Number Supplement Number
    K990997 000