BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Saturn 5 Laser System

    DI: 05060488043406 · Model: Saturn 5 Fixed Leica DMi8 40x · RESEARCH INSTRUMENTS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Saturn 5 Laser System
    Primary DI
    05060488043406
    Version / Model
    Saturn 5 Fixed Leica DMi8 40x
    Catalog Number
    6-47-501-03
    Company Name
    RESEARCH INSTRUMENTS LIMITED
    Labeler DUNS
    536139413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-23
    Public Version
    4
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    2fea211f-422b-4284-81b5-8a2d1d0fef53

    Device Description

    Assisted Reproduction Laser

    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRX System, assisted reproduction laser

    GMDN Terms

    Code Name
    61181 Assisted reproduction laser system

    Identifiers

    Type ID
    Primary 05060488043406

    Customer Contacts

    Phone
    +4546790202
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141434 000