- Physicians Office Resource

Ultra Long RFA Focal Catheter 80 Applications
Barrx - 90-9200

Device Description

A semi-flexible tubular device with a bipolar electrode(s) at its distal end intended to be endoscopically introduced into the gastrointestinal (GI) tract (e.g., oesophagus, stomach, rectum, anus) to deliver radio-frequency (RF) current from a connected RF generator (not included) for focal ablation of a GI lesion (e.g., neoplasm); it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a closed fluid circuit for cooling of the tip. This is a single-use device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

N/A
79.00

Handling Environment Humidity - Percent (%) Relative Humidity

65.00
20.00

Handling Environment Temperature - Degrees Celsius

30.00
20.00

Special Storage Condition, Specify

Keep dry

Device Sizes

Length: 40 Millimeter

Width: 13 Millimeter

Length: 40 Millimeter
Width: 13 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Identifiers

Device Id: 10884521581838

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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