Xspot 55741

GUDID 04056481005245

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481005245
• NIH Device Record Key: bcbfb6c6-2711-41ea-93ff-6912ac9a1e96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xspot
• Version Model Number: 55741
• Catalog Number: 55741
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481005245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110204

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481005245]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-15

Devices Manufactured by Brainlab AG

• 04056481146108 - Hex Screwdriver 4 mm: 2025-08-22
• 04056481146528 - Hex Screwdriver 2.5 mm: 2025-08-22
• 04056481146672 - Mixed Reality Spine Navigation: 2025-08-08
• 04056481145941 - Disposable Loop-X Source Drape (1 Pc): 2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X.
• 04056481145934 - Disposable Loop-X Detector Drape (1 Pc): 2025-08-01 Is intended to sterile cover the detector of the Loop-X.
• 04056481145330 - CRANIAL 4PI HEADREST PLATFORM: 2025-07-04
• 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD: 2025-07-04
• 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.): 2025-07-04