Cranial 22216-01A

GUDID 04056481000479

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481000479
• NIH Device Record Key: 627a0557-62af-45fa-9548-8d8335071bb2
• Commercial Distribution Discontinuation: 2018-11-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cranial
• Version Model Number: 3.1
• Catalog Number: 22216-01A
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481000479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological 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: 4
• Public Version Date: 2018-11-21
• Device Publish Date: 2016-09-15

On-Brand Devices [Cranial]

• 04056481000493: 2.1
• 04056481000479: 3.1