Vascular Navigation PAD

GUDID 04056481145613

Brainlab SE

Angiographic x-ray system application software

• Primary Device ID: 04056481145613
• NIH Device Record Key: db9286e5-5952-470e-86fc-5e8c9af1fa74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascular Navigation PAD
• Version Model Number: 2.0
• Company DUNS: 314482980
• Company Name: Brainlab SE
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481145613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243432

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2025-09-19
• Device Publish Date: 2025-09-11

Devices Manufactured by Brainlab SE

• 04056481145613 - Vascular Navigation PAD: 2025-09-19
• 04056481145613 - Vascular Navigation PAD: 2025-09-19
• 04056481141981 - HIP7: 2025-09-17