ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)

GUDID 04056481144166

Brainlab AG

Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit Neurosurgical ultrasound navigation system optical tracking unit 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

• 04056481144753 - Drill Guide Array: 2024-06-12
• 04056481144760 - Drill Guide Depth Control (60 - 100 mm): 2024-06-12
• 04056481144777 - Drill Guide Depth Control (0 - 60 mm): 2024-06-12
• 04056481144784 - Drill Guide Tube (4.5 mm): 2024-06-12
• 04056481144791 - Drill Guide Tube (3.2 mm): 2024-06-12
• 04056481144807 - Drill Guide Tube (2.6 mm): 2024-06-12
• 04056481144814 - Drill Guide Tube (2.4 mm): 2024-06-12
• 04056481144821 - Drill Guide Tube (2.0 mm): 2024-06-12