BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgical Eye Shield

    DI: 00854428006010 · Model: Pediatric Green · Jardon Eye Prosthetics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surgical Eye Shield
    Primary DI
    00854428006010
    Version / Model
    Pediatric Green
    Company Name
    Jardon Eye Prosthetics, Inc.
    Labeler DUNS
    118972350
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-26
    Public Version
    1
    Public Version Date
    2023-07-04
    Public Version Status
    New
    Public Device Record Key
    4e66077f-4da1-4e62-955e-970cfb5ca4bb

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

    GMDN Terms

    Code Name
    61943 Surgical eye pressure shield

    Identifiers

    Type ID
    Primary 00854428006010