BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SUMMIT MEDICAL

    DI: 00385640061469 · Model: FL3000-05 · Summit Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SUMMIT MEDICAL
    Primary DI
    00385640061469
    Version / Model
    FL3000-05
    Company Name
    Summit Medical, Inc.
    Labeler DUNS
    965484699
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-12
    Public Version
    1
    Public Version Date
    2022-12-20
    Public Version Status
    New
    Public Device Record Key
    de9a5aa5-d28a-4429-bb93-77a22c63b337

    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
    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
    MUU System, Suction, Lipoplasty

    GMDN Terms

    Code Name
    36894 Liposuction system

    Identifiers

    Type ID
    Primary 00385640061469

    Premarket Submissions

    Submission Number Supplement Number
    K092284 000
    K092482 000