Venclose System EVSRF Catheter

GUDID 00858254006015

Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm

VENCLOSE INC

Radio-frequency ablation system

• Primary Device ID: 00858254006015
• NIH Device Record Key: 67e0bcc2-8af6-4226-93ab-4d4dc573649b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venclose System EVSRF Catheter
• Version Model Number: VC-10A2.5-6F-100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858254006015 [Primary]
GS1	00858254006206 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00858254006220 [Package]; Package: Box [5 Units]; In Commercial Distribution

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: true

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

On-Brand Devices [Venclose System EVSRF Catheter]

• 00858254006015: Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm
• 00858254006008: Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm