BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Croma Generator

    DI: 05060359560513 · Model: 7-EMR-050 V6.01 · CREO MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Croma Generator
    Primary DI
    05060359560513
    Version / Model
    7-EMR-050 V6.01
    Catalog Number
    7-EMR-050
    Company Name
    CREO MEDICAL LIMITED
    Labeler DUNS
    733853373
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-09
    Public Version
    1
    Public Version Date
    2024-01-17
    Public Version Status
    New
    Public Device Record Key
    ba8a3bc4-075c-4463-9c7a-8052a602fd02

    Device Description

    A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    GMDN Terms

    Code Name
    63396 Microwave/electrosurgical system generator

    Identifiers

    Type ID
    Primary 05060359560513

    Customer Contacts

    Phone
    +18662261170
    Email
    [email protected]
    Phone
    +441291637300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K171983 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    69 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    20 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 30 Degrees Celsius