AccessGUDID - DEVICE: Intracept RF Probe (00852454006295)

GUDID

Device Identifier (DI) Information

Brand Name: Intracept RF Probe
Version or Model: RLV 0015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Relievant Medsystems, Inc.

Primary DI Number: 00852454006295
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 099324362 *Terms of Use

Device Description: Intracept RF Probe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, Radiofrequency Lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5af9b8ec-f57c-4638-ac91-eff3c522de4b
Public Version Date: April 16, 2024
Public Version Number: 4
DI Record Publish Date: February 24, 2023