BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mederi MDRF1 Generator

    DI: 00856219002102 · Model: MDRF1 · MEDERI THERAPEUTICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mederi MDRF1 Generator
    Primary DI
    00856219002102
    Version / Model
    MDRF1
    Catalog Number
    177-5150
    Company Name
    MEDERI THERAPEUTICS INC.
    Labeler DUNS
    022785895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    2c323aa8-de28-4457-8ccc-51141d72be4e

    Device Description

    Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters

    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
    No
    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 00856219002102

    Customer Contacts

    Phone
    2039309980
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103017 000