Veloxion 2516

GUDID 00860011104445

Veloxion Controller Kit

Aulea Medical Inc.

Resectoscope

• Primary Device ID: 00860011104445
• NIH Device Record Key: ebb7e089-6326-4310-98b2-6a34322ec529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veloxion
• Version Model Number: 2516
• Catalog Number: 2516
• Company DUNS: 119365804
• Company Name: Aulea Medical 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

Customer Support Contacts

• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011104445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230205

FDA Product Code

• FJL: Resectoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [Veloxion]

• 00860011104452: Veloxion Roll Stand
• 00860011104445: Veloxion Controller Kit
• 00860011104483: Tissue Catch
• 00860011104421: Waste Management Tubing
• 00860011104414: Veloxion Fluid Control Set
• 00860011104407: Veloxion Resectoscope