BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OC-2200

    DI: 00850053428555 · Model: 24046-CH-L1-011 · TOPCON HEALTHCARE INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    OC-2200
    Primary DI
    00850053428555
    Version / Model
    24046-CH-L1-011
    Company Name
    TOPCON HEALTHCARE INC
    Labeler DUNS
    053547238
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-12
    Public Version
    2
    Public Version Date
    2024-09-11
    Public Version Status
    Update
    Public Device Record Key
    9c30c5cc-a8ce-4802-a66f-16c73f4bab99

    Device Description

    OC-2200 CHAIR CHARCOAL 120V LOW WIRELESS; Ophthalmic examination chair

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HME Chair, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    15723 Ophthalmic chair, line-powered

    Identifiers

    Type ID
    Primary 00850053428555