AccessGUDID - DEVICE: VESALIUS STERILE single-use endoscopic probe for ablation (08034055293850)

GUDID

Device Identifier (DI) Information

Brand Name: VESALIUS STERILE single-use endoscopic probe for ablation
Version or Model: STERILE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2610004
Company Name: TELEA ELECTRONIC ENGEENERING SRL

Primary DI Number: 08034055293850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435331459 *Terms of Use

Device Description: No description.

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":	Yes
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?
61931	Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b19b5d21-e62d-4d0b-8bc9-2563c0d7a55e
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016