Croma 7-RS2-210

GUDID 05060359560070

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.

CREO MEDICAL LIMITED

Electrical-only medical device connection cable, single-use

• Primary Device ID: 05060359560070
• NIH Device Record Key: bfc7b0ac-9367-4489-927d-d624934f741f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Croma
• Version Model Number: Interface Cable
• Catalog Number: 7-RS2-210
• Company DUNS: 733853373
• Company Name: CREO MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +441291637300
• Email: customerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 KiloPascal and 90 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060359560070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171983

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [Croma]

• 05060359560070: A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed
• 05060359560223: A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy
• 05060359560292: A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste