BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Croma

    DI: 05060359560070 · Model: Interface Cable · CREO MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Croma
    Primary DI
    05060359560070
    Version / Model
    Interface Cable
    Catalog Number
    7-RS2-210
    Company Name
    CREO MEDICAL LIMITED
    Labeler DUNS
    733853373
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-23
    Public Version
    2
    Public Version Date
    2023-11-09
    Public Version Status
    Update
    Public Device Record Key
    bfc7b0ac-9367-4489-927d-d624934f741f

    Device Description

    A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    47143 Electrical-only medical device connection cable, single-use

    Identifiers

    Type ID
    Primary 05060359560070

    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 Temperature
    Temperature Range
    10 – 30 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    20 – 90 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    69 – 106 KiloPascal