HIP7

GUDID 04056481141981

Brainlab SE

Robotic surgical navigation system

• Primary Device ID: 04056481141981
• NIH Device Record Key: 8017562b-d561-4fef-9f0e-711a4cfc1064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIP7
• Version Model Number: 7.0
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com
• Phone: +4989991568
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481141981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193307

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-09-17
• Device Publish Date: 2020-06-08