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

Endoscopic electrosurgical/microwave submucosal lift/resection instrument
Primary Device ID05060359560599
NIH Device Record Key6c6b920e-4b09-4ad5-bd78-c7d78f0d5441
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedboat RS2 8 Fr Instrument
Version Model Number7-RS2-003
Catalog Number7-RS2-003
Company DUNS733853373
Company NameCREO MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com

Device Dimensions

Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter
Outer Diameter2.65 Millimeter
Catheter Length2.3 Meter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105060359560575 [Primary]
GS105060359560599 [Package]
Contains: 05060359560575
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

Devices Manufactured by CREO MEDICAL LIMITED

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05060359560650 - Speedboat Ultraslim (SB1L) Electrosurgical Instrument2023-12-14 Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasi
05060359560599 - Speedboat RS2 8 Fr Instrument2023-11-16A 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 Instrument2023-11-16 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
05060359560193 - Microblate Flex2021-08-06 The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of sof
05060359560292 - Croma2021-03-23 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)
05060359560223 - Croma2021-01-08 A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy to tissues for coagulation, whil
05060359560070 - Croma2020-12-01 A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and
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