Guide 1.8 Biopsy UI 55980-01

GUDID 04056481094713

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481094713
• NIH Device Record Key: 4e28ec95-8946-40ec-906e-31b0a0c2bb84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide 1.8 Biopsy UI
• Version Model Number: 55980-01
• Catalog Number: 55980-01
• 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	04056481094713 [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

[04056481094713]

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

Devices Manufactured by Brainlab AG

• 04056481143916 - Spine Planning: 2024-11-13
• 04056481144654 - Viewer 5.4: 2024-11-13
• 04056481143527 - DICOM Proxy: 2024-11-01
• 04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.): 2024-07-26
• 04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.): 2024-07-26
• 04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.): 2024-07-26
• 04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.): 2024-07-26
• 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.): 2024-07-26