BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Orbital Implant Inserter

    DI: 05060171621850 · Model: INSTR01 · CERAMISYS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Orbital Implant Inserter
    Primary DI
    05060171621850
    Version / Model
    INSTR01
    Company Name
    CERAMISYS LTD
    Labeler DUNS
    423459374
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-07-31
    Public Version
    3
    Public Version Date
    2021-10-21
    Public Version Status
    Update
    Public Device Record Key
    180e6e1c-6e10-4286-835b-c7cd0af09d71
    Distribution End Date
    2021-10-20

    Device Description

    Orbital Implant Inserter

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HNP Introducer, Sphere

    GMDN Terms

    Code Name
    32766 Orbital sphere implant introducer

    Identifiers

    Type ID
    Primary 05060171621850