Venclose System digiRF Generator

GUDID 00858254006022

Radiofrequency Ablation (RFA) Generator

VENCLOSE INC

Radio-frequency ablation system

• Primary Device ID: 00858254006022
• NIH Device Record Key: 01b03cb8-c16b-4743-91bd-ff62086aee27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venclose System digiRF Generator
• Version Model Number: VC-RFG-1
• Company DUNS: 085838983
• Company Name: VENCLOSE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858254006022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160754

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-01

Devices Manufactured by VENCLOSE INC

• 00858254006404 - Venclose Maven Catheter: 2024-04-11 Venclose Perforator Catheter
• 40858254006365 - EVSRF Procedure Pack: 2020-11-06 Venclose procedure pack - convenient kit.
• 00858254006039 - Venclose System Foot Pedal: 2018-07-06 Foot Pedal
• 00858254006008 - Venclose System EVSRF Catheter: 2018-07-06 Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm
• 00858254006015 - Venclose System EVSRF Catheter: 2018-07-06 Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm
• 00858254006022 - Venclose System digiRF Generator: 2018-07-06Radiofrequency Ablation (RFA) Generator
• 00858254006022 - Venclose System digiRF Generator: 2018-07-06 Radiofrequency Ablation (RFA) Generator
• 00858254006046 - Venclose System Power Cord: 2018-07-06 Power Cord, US
• 00858254006053 - Venclose System Power Cord: 2018-07-06 Power Cord, Germany, Finland, Netherlands, Spain, Turkey, France, Belgium, Czech Republic, Poland