BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INSTRUSAFE

    DI: 00385640055475 · Model: IN-2020-3221 · Summit Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INSTRUSAFE
    Primary DI
    00385640055475
    Version / Model
    IN-2020-3221
    Company Name
    Summit Medical, Inc.
    Labeler DUNS
    965484699
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-08
    Public Version
    6
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    dca8339b-fb91-4820-bf85-2d856a42b9d8

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00385640055475

    Premarket Submissions

    Submission Number Supplement Number
    K051157 000
    K133015 000
    K140289 000
    K141513 000
    K142630 000
    K142768 000
    K150540 000
    K151166 000