BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PerFect TCS

    DI: D661S7010A0 · Model: S7010A · COLTENE/WHALEDENT INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PerFect TCS
    Primary DI
    D661S7010A0
    Version / Model
    S7010A
    Company Name
    COLTENE/WHALEDENT INC
    Labeler DUNS
    622185718
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-16
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    7fcbb3f3-6711-4b00-af22-294191b5dd63

    Device Description

    3 Sterilizable Electrode Sheaths

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKZ Unit, Electrosurgical, And Accessories, Dental

    GMDN Terms

    Code Name
    11490 Electrosurgical system generator

    Identifiers

    Type ID
    Primary D661S7010A0

    Customer Contacts

    Phone
    3309168800
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K071632 000