Creo Medical

GUDID 05060359560087

A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) e

CREO MEDICAL LIMITED

Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator
Primary Device ID05060359560087
NIH Device Record Keye132567b-771c-4497-a64e-7465b0279dfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCreo Medical
Version Model NumberGenerator 7-EMR-050
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441291637300
Emailcustomerservice@creomedical.co
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060359560087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-15

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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