Croma Generator 7-EMR-050

GUDID 05060359560919

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.

CREO MEDICAL LIMITED

Microwave/electrosurgical system generator

• Primary Device ID: 05060359560919
• NIH Device Record Key: 5de9375c-97cb-40d6-9696-886c9448899b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Croma Generator
• Version Model Number: 7-EMR-050 V6.001
• Catalog Number: 7-EMR-050
• Company DUNS: 733853373
• Company Name: CREO MEDICAL LIMITED
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +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
• 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 Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060359560513 [Previous]
GS1	05060359560919 [Primary]
GS1	05060359560926 [Package]; Package: Carton [1 Units]; In Commercial Distribution

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: 2024-10-16
• Device Publish Date: 2024-10-08

Devices Manufactured by CREO MEDICAL LIMITED

• 05060359560919 - Croma Generator: 2024-10-16A 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.
• 05060359560919 - Croma Generator: 2024-10-16 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)
• 05060359560629 - Reusable Interface Cable, 1.5 m: 2024-09-09 The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA E
• 05060359560650 - Speedboat Ultraslim (SB1L) Electrosurgical Instrument: 2023-12-14 Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasi
• 05060359560599 - Speedboat RS2 8 Fr Instrument: 2023-11-16 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
• 05060359560193 - Microblate Flex: 2021-08-06 The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of sof
• 05060359560292 - Croma: 2021-03-23 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)
• 05060359560223 - Croma: 2021-01-08 A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy to tissues for coagulation, whil
• 05060359560070 - Croma: 2020-12-01 A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and