BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ri-former® diagn. station for rail, 2 handles, 3,5V / 120V, without clamp

    DI: 04045396189218 · Model: 3653-400 · Rudolf Riester GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ri-former® diagn. station for rail, 2 handles, 3,5V / 120V, without clamp
    Primary DI
    04045396189218
    Version / Model
    3653-400
    Catalog Number
    3653-400
    Company Name
    Rudolf Riester GmbH
    Labeler DUNS
    537208717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    216ca2b1-22d4-4801-b278-cbaec4c477ce

    Device Description

    Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis.

    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
    HLJ Ophthalmoscope, Battery-Powered

    GMDN Terms

    Code Name
    11585 ENT examination/treatment system

    Identifiers

    Type ID
    Primary 04045396189218

    Premarket Submissions

    Submission Number Supplement Number
    K950914 000