BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    13063 RxSight 0.766x Mag Contact Lens

    DI: 00630238122245 · Model: 13063 · OCULAR INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    13063 RxSight 0.766x Mag Contact Lens
    Primary DI
    00630238122245
    Version / Model
    13063
    Company Name
    OCULAR INSTRUMENTS, INC.
    Labeler DUNS
    046212387
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-11
    Public Version
    2
    Public Version Date
    2020-05-19
    Public Version Status
    Update
    Public Device Record Key
    1c9c4a69-791e-48e4-adc9-df4ff1e43508

    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
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

    GMDN Terms

    Code Name
    40238 Laser lens, ophthalmic, surgical

    Identifiers

    Type ID
    Primary 00630238122245
    Direct Marking 00630238122269

    Premarket Submissions

    Submission Number Supplement Number
    K872136 000