BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Coblation

    DI: 00817470004588 · Model: H2000-04 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Coblation
    Primary DI
    00817470004588
    Version / Model
    H2000-04
    Catalog Number
    H2000-04
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-29
    Public Version
    7
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    ab56dc6c-7e8d-47b8-b57b-08199571b0ca
    Distribution End Date
    2022-03-17

    Device Description

    SYSTEM 2000 FOOT CONTROL

    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
    No
    Has Lot/Batch Number
    Yes
    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 00817470004588

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K011634 000