Venapax

GUDID M718VPX3000

END OF DISTRIBUTION SEPTEMBER 09, 2024.

SAPHENA MEDICAL, INC.

Flexible endoscopic scissors, reusable

• Primary Device ID: M718VPX3000
• NIH Device Record Key: c3c518e7-739b-47c7-966e-64ba0d0291bb
• Commercial Distribution Discontinuation: 2025-04-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Venapax
• Version Model Number: VPX3000
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M718VPX3000 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-09
• Device Publish Date: 2025-04-29

On-Brand Devices [Venapax]

• M718VPX4000: The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimall
• M718VPX3000: END OF DISTRIBUTION SEPTEMBER 09, 2024.