AccessGUDID - DEVICE: Venclose™ EVSRF™ Catheter (00858254006169)

GUDID

Device Identifier (DI) Information

Brand Name: Venclose™ EVSRF™ Catheter
Version or Model: VC-10A2.5-6F-60 [5X]
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENCLOSE INC

Primary DI Number: 00858254006169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085838983 *Terms of Use

Device Description: Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
62233	Peripheral vascular electrocautery catheter, single-use	A flexible catheter with a distal heating element/electrode intended to be connected to an electrical generator and introduced into the peripheral vasculature to ablate venous tissues, through direct application of heat, as a treatment for venous reflux disease (varicose veins); it is not intended to introduce electrical current into the body. It is a luminal device with a proximal handle with controls (e.g., on/off switch) that is introduced via an introducer assembly (which may be included), and is typically maneuvered under external image guidance [e.g., ultrasound (US)]. 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 [?]
K160754	000

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
Length: 60 Centimeter

Device Record Status

Public Device Record Key: 5064430b-3ed2-4602-8a99-cc40acbfd0eb
Public Version Date: July 24, 2023
Public Version Number: 4
DI Record Publish Date: November 01, 2016