Primary Device ID | 05060359560025 |
NIH Device Record Key | 17a07c0e-4ef9-4eec-ac46-a1cfb6ed6912 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Creo Medical |
Version Model Number | 7-RS2-001 |
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 |
Catheter Length | 2.3 Meter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Outer Diameter | 3.7 Millimeter |
Catheter Length | 2.3 Meter |
Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
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 Issuing Agency | Device ID |
---|---|
GS1 | 05060359560025 [Primary] |
GS1 | 05060359560049 [Package] Package: Shipper Box [5 Units] In Commercial Distribution |
KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2018-11-14 |
05060359560124 | A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste |
05060359560087 | A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste |
05060359560063 | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed |
05060359560025 | A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal l |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CREO MEDICAL 79267981 not registered Live/Pending |
Creo Medical Ltd 2019-07-31 |