Venapax VPX4000

GUDID M718VPX4000

The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.

SAPHENA MEDICAL, INC.

Flexible endoscopic scissors, reusable

• Primary Device ID: M718VPX4000
• NIH Device Record Key: 37046c1a-5626-4b47-9eec-1bc352ae79ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venapax
• Version Model Number: VPX4000
• Catalog Number: VPX4000
• Company DUNS: 021317541
• Company Name: SAPHENA MEDICAL, 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: false
• 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

Customer Support Contacts

• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com
• Phone: 949-285-3517
• Email: cblake@saphenamedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -31 Degrees Celsius and 62 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M718VPX4000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140603

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-14
• Device Publish Date: 2024-06-06