ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)

GUDID 04056481144166

Brainlab AG

Neurosurgical ultrasound navigation system optical tracking unit

• Primary Device ID: 04056481144166
• NIH Device Record Key: 778f11c8-5a68-4f57-aec5-01148baf3108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
• Version Model Number: 41860-35C
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481144166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192703

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

[04056481144166]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by Brainlab AG

• 04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S: 2025-06-25
• 04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L: 2025-06-25
• 04056481146320 - Alignment Software Spine: 2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
• 04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K): 2025-06-23
• 04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP): 2025-06-23
• 04056481145828 - Microscope Navigation: 2025-06-19
• 04056481143985 - Mixed Reality Spine Navigation: 2025-06-09
• 04056481140809 - Curve 1.2 Dual Navigation Station: 2025-03-26