AccessGUDID - DEVICE: Endovenous Radiofrequency Ablation (RFA) Catheter (08600360005022)

GUDID

Device Identifier (DI) Information

Brand Name: Endovenous Radiofrequency Ablation (RFA) Catheter
Version or Model: VEN-3-60
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VEN-3-60
Company Name: Vein360 LLC

Primary DI Number: 08600360005022
Issuing Agency: GS1
Commercial Distribution End Date: November 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080926907 *Terms of Use

Device Description: Endovenous Radiofrequency Ablation (RFA) Catheter 3-60

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?
57972	Radio-frequency ablation system	An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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: f5fde442-f9ef-4482-a19e-2d8e1dacfed8
Public Version Date: November 09, 2023
Public Version Number: 3
DI Record Publish Date: June 17, 2021