EVSRF Procedure Pack

GUDID 40858254006365

Venclose procedure pack - convenient kit.

VENCLOSE INC

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 40858254006365
• NIH Device Record Key: b25504ee-c5a5-4940-b5f3-71fab2c7bae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVSRF Procedure Pack
• Version Model Number: VC-PP-EVSRF
• Company DUNS: 085838983
• Company Name: VENCLOSE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10858254006364 [Primary]
GS1	40858254006365 [Package]; Contains: 10858254006364; Package: box [5 Units]; In Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-06
• Device Publish Date: 2018-01-21

Devices Manufactured by VENCLOSE INC

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• 40858254006365 - EVSRF Procedure Pack: 2020-11-06Venclose procedure pack - convenient kit.
• 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: 2018-07-06 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