Speedboat Notch Long PRD-SB1-003

GUDID 05060359561077

Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract

CREO MEDICAL LIMITED

Endoscopic electrosurgical/microwave submucosal lift/resection instrument

• Primary Device ID: 05060359561077
• NIH Device Record Key: 8d698e4e-669c-41bd-bdfb-f2156df28712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speedboat Notch Long
• Version Model Number: PRD-SB1-003
• Catalog Number: PRD-SB1-003
• Company DUNS: 733853373
• Company Name: CREO MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter

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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00560359561053 [Package]; Package: Carton [1 Units]; In Commercial Distribution
GS1	05060359561015 [Package]; Contains: 00560359561053; Package: 1-UP Shipper [1 Units]; In Commercial Distribution
GS1	05060359561039 [Package]; Contains: 00560359561053; Package: 5-UP Shipper [5 Units]; In Commercial Distribution
GS1	05060359561077 [Primary]

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: 2025-04-03
• Device Publish Date: 2025-03-26

Devices Manufactured by CREO MEDICAL LIMITED

• 05060359561077 - Speedboat Notch Long: 2025-04-03Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
• 05060359561077 - Speedboat Notch Long: 2025-04-03 Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, c
• 05060359561213 - CROMA Electrosurgical Generator: 2025-02-18 The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA E
• 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)