Kick 2 Navigation Station

GUDID 04056481143503

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481143503
• NIH Device Record Key: b0e3061a-2dca-4174-b456-bf3736b8ad06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kick 2 Navigation Station
• Version Model Number: 18200
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481143503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192703

FDA Product Code

• HAW: Neurological Stereotaxic Instrument
• OLO: Orthopedic Stereotaxic Instrument

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: 2021-06-08
• Device Publish Date: 2021-05-31

On-Brand Devices [Kick 2 Navigation Station]

• 04056481006655: 18170
• 04056481143503: 18200