BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MaxAC® 28D Binocular Indirect Lens

    DI: 00630238077491 · Model: OI-28A · OCULAR INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MaxAC® 28D Binocular Indirect Lens
    Primary DI
    00630238077491
    Version / Model
    OI-28A
    Company Name
    OCULAR INSTRUMENTS, INC.
    Labeler DUNS
    046212387
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-11
    Public Version
    3
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    f888299d-6b22-4b63-bd34-32db25afd31c

    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
    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
    High-level Disinfectant

    Product Codes

    Code Name
    HJL Lens, Condensing, Diagnostic

    GMDN Terms

    Code Name
    47946 Ophthalmic diagnostic condensing lens

    Identifiers

    Type ID
    Primary 00630238077491
    Direct Marking 00630238077545