Drill Guide Kit (0.075'') 19769

GUDID 04056481006457

Brainlab AG

Surgical drill guide, single-use, sterile Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use

• Primary Device ID: 04056481006457
• NIH Device Record Key: c1c7c54d-4a2c-44e7-822c-8873ec045ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Guide Kit (0.075'')
• Version Model Number: 19769
• Catalog Number: 19769
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481006457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123605

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)
• HCA: Catheter, Ventricular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-15

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