Kick 2 Navigation Station

GUDID 04056481006655

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481006655
• NIH Device Record Key: 8e8aa899-2958-4453-a16a-01c17ee111ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kick 2 Navigation Station
• Version Model Number: 18170
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481006655 [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: 2019-11-20
• Device Publish Date: 2016-11-25

On-Brand Devices [Kick 2 Navigation Station]

• 04056481006655: 18170
• 04056481143503: 18200