Sleeve_10mm 41960

GUDID 04056481125806

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481125806
• NIH Device Record Key: 717cc9b1-3875-4847-b776-4f19d8ba4404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleeve_10mm
• Version Model Number: 41960
• Catalog Number: 41960
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: true
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481125806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481125806]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-10
• Device Publish Date: 2020-04-02

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• 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.): 2024-07-26