PROBE APSC01 50MM 10MM ENHANCED
Accurian - APSC01
Device Description
A hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] 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 or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.
Environmental Conditions
- Store between -20°C and 50°C
Device Sizes
- Needle Gauge: 17.0 Gauge
- Length: 50.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
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: 00763000153441
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