Nitinol Electrode
Venom - 0406825010
Device Description
A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.
Environmental Conditions
- 106.00
- 50.00
- 75.00
- 10.00
- 65.00
- -34.00
Device Sizes
- Length: 100.0 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: GXI
Device Name: Probe, Radiofrequency Lesion
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
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: 882.4725
Third Party Flag: Y
Medical Specialty: NE
Device IdentifiersDevice Id: 07613327118537
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