BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MT B500-0L240 Straight Microtip

    DI: 07332834000370 · Model: MT B500-0L240 · Perimed AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    MT B500-0L240 Straight Microtip
    Primary DI
    07332834000370
    Version / Model
    MT B500-0L240
    Company Name
    Perimed AB
    Labeler DUNS
    354765570
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2020-04-15
    Public Version
    2
    Public Version Date
    2023-02-01
    Public Version Status
    Update
    Public Device Record Key
    9e7a399e-7ca6-449a-9229-f286e857b06f
    Distribution End Date
    2023-02-01

    Device Description

    MT B500-0L240 Straight Microtip

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60451 Laser Doppler blood flowmeter

    Identifiers

    Type ID
    Unit of Use 07332834000394
    Primary 07332834000370

    Premarket Submissions

    Submission Number Supplement Number
    K935495 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 65 Degrees Celsius