BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENVISION 3D: IMAGE GUIDANCE SYSTEM

    DI: 00627843746614 · Model: 10-0001 · 7D Surgical ULC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENVISION 3D: IMAGE GUIDANCE SYSTEM
    Primary DI
    00627843746614
    Version / Model
    10-0001
    Company Name
    7D Surgical ULC
    Labeler DUNS
    204326292
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-12
    Public Version
    3
    Public Version Date
    2022-04-15
    Public Version Status
    Update
    Public Device Record Key
    12790be7-40ad-4af9-9734-7d7a5886115c

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    61409 Optical surgical navigation device tracking system workstation, mobile

    Identifiers

    Type ID
    Primary 00627843746614