BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultrasonic Biometer for Ophthalmology

    DI: 06948941111109 · Model: MD-1000A · Meda Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ultrasonic Biometer for Ophthalmology
    Primary DI
    06948941111109
    Version / Model
    MD-1000A
    Company Name
    Meda Co., Ltd
    Labeler DUNS
    545188828
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    0ed45f73-7ad0-4a2d-8dbf-15b3667c0e63

    Device Description

    MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.

    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
    Yes
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 06948941111109