Intracept

Basic Information

• Brand Name: Intracept
• Primary DI: 00852454006196
• Version / Model: RLV PK
• Catalog Number: RLV PK
• Company Name: RELIEVANT MEDSYSTEMS, INC.
• Labeler DUNS: 808344183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 3
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 58b401b9-c5b9-49b4-a59e-d5b8a3e1b155

Device Description

Contains: (1) Intracept RF Probe and (1) Intracept Access Instruments

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	Probe, Radiofrequency Lesion	Neurology	882.4725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active
61932	Percutaneous radio-frequency ablation probe, denervation, bipolar	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 bipolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal bipolar 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852454006196	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 120 Degrees Fahrenheit