BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    rezum Generator

    DI: 00855357006003 · Model: G2200 · NXTHERA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    rezum Generator
    Primary DI
    00855357006003
    Version / Model
    G2200
    Company Name
    NXTHERA, INC.
    Labeler DUNS
    947824194
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-17
    Public Version
    6
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    3fb1f458-64f8-452b-aa7f-9261c7e8497c

    Device Characteristics

    Single Use
    No
    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
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    11490 Electrosurgical system generator

    Identifiers

    Type ID
    Primary 00855357006003