Speedboat RS2 8 Fr Instrument 7-RS2-003

GUDID 05060359560599

A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.

CREO MEDICAL LIMITED

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• Primary Device ID: 05060359560599
• NIH Device Record Key: 6c6b920e-4b09-4ad5-bd78-c7d78f0d5441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speedboat RS2 8 Fr Instrument
• Version Model Number: 7-RS2-003
• Catalog Number: 7-RS2-003
• 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: +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
• 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

Device Dimensions

• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter
• Outer Diameter: 2.65 Millimeter
• Catheter Length: 2.3 Meter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060359560575 [Primary]
GS1	05060359560599 [Package]; Contains: 05060359560575; Package: Carton [5 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

Devices Manufactured by CREO MEDICAL LIMITED

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• 05060359560599 - Speedboat RS2 8 Fr Instrument: 2023-11-16A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
• 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
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• 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
• 05060359560025 - Creo Medical: 2020-02-06 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
• 05060359560124 - Creo Medical: 2019-03-28 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)