ClearLens Tracking Array Set for Knee 53236

GUDID 04056481005535

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481005535
• NIH Device Record Key: dafa82a8-7bc4-4fe7-b0f5-5a693fb71a11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLens Tracking Array Set for Knee
• Version Model Number: 53236
• Catalog Number: 53236
• 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: true
• 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
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481005535 [Primary]
GS1	04056481006709 [Package]; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102990

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-10

Devices Manufactured by Brainlab AG

• 04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S: 2025-06-25
• 04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L: 2025-06-25
• 04056481146320 - Alignment Software Spine: 2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
• 04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K): 2025-06-23
• 04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP): 2025-06-23
• 04056481145828 - Microscope Navigation: 2025-06-19
• 04056481143985 - Mixed Reality Spine Navigation: 2025-06-09
• 04056481140809 - Curve 1.2 Dual Navigation Station: 2025-03-26