Creo Medical

GUDID 05060359560025

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 ID05060359560025
NIH Device Record Key17a07c0e-4ef9-4eec-ac46-a1cfb6ed6912
Commercial Distribution StatusIn Commercial Distribution
Brand NameCreo Medical
Version Model Number7-RS2-001
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+4401291637300
Emailcustomerservice@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

Catheter Length2.3 Meter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter
Outer Diameter3.7 Millimeter
Catheter Length2.3 Meter

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
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
GS105060359560025 [Primary]
GS105060359560049 [Package]
Package: Shipper Box [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2018-11-14

On-Brand Devices [Creo Medical]

05060359560124A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste
05060359560087A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste
05060359560063A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed
05060359560025A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal l

Trademark Results [Creo Medical]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CREO MEDICAL
CREO MEDICAL
79267981 not registered Live/Pending
Creo Medical Ltd
2019-07-31

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