Adj Cutb - Fem Align Guide 53212A

GUDID 04056481001834

Brainlab AG

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system

• Primary Device ID: 04056481001834
• NIH Device Record Key: 13f608fe-eb38-438c-bde1-c7cbf6f06b05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adj Cutb - Fem Align Guide
• Version Model Number: 53212A
• Catalog Number: 53212A
• 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: true
• 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	04056481001834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102990

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

Moist Heat or Steam Sterilization

[04056481001834]

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 [Adj Cutb - Fem Align Guide]

• 04056481005580: 53212
• 04056481001834: 53212A