Bl Pointer, Square-Angled 52852

GUDID 04056481005757

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481005757
• NIH Device Record Key: 480bb35b-17c2-43cf-8285-5598d1609f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bl Pointer, Square-Angled
• Version Model Number: 52852
• Catalog Number: 52852
• 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: 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	04056481005757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083483

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481005757]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Bl Pointer, Square-Angled]

• 04056481005757: 52852
• 04056481002114: 52852A