Em Disposable Stylet US18097

GUDID 04056481006914

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481006914
• NIH Device Record Key: e4b8bc30-f132-43c5-868f-450356a22e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Em Disposable Stylet
• Version Model Number: US18097
• Catalog Number: US18097
• 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: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481006907 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	04056481006914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological 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: 2016-09-15

On-Brand Devices [Em Disposable Stylet]

• 04056481006914: US18097
• 04056481004958: 18097