Pedicle Access Guide Tube 55844A

GUDID 04056481001049

Brainlab AG

Robotic surgical navigation system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481001049
• NIH Device Record Key: 3c52deba-3fdf-4c3a-bd33-7b86cae4dff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedicle Access Guide Tube
• Version Model Number: 55844A
• Catalog Number: 55844A
• 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: 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
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com
• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481001049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070106
• Premarket Notification: K183605

FDA Product Code

• HAW: Neurological Stereotaxic Instrument
• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

[04056481001049]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

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