Curve Navigation 17700

GUDID 04056481142520

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481142520
• NIH Device Record Key: a796460c-a6e8-45a5-8dcd-930d34c2e734
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curve Navigation 17700
• Version Model Number: 17700
• 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	04056481142520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183605

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: 2020-06-02
• Device Publish Date: 2020-05-25

On-Brand Devices [Curve Navigation 17700]

• 04056481142520: 17700
• 04056481144500: 17701