NICO BrainPath

GUDID 10816744028326

Sheath 11 mm x 60 mm

NICO CORPORATION

Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula Neurosurgical retraction cannula

• Primary Device ID: 10816744028326
• NIH Device Record Key: eb5e32ab-4316-4491-a138-17c1affc1ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO BrainPath
• Version Model Number: NN-8032
• Company DUNS: 829838288
• Company Name: NICO CORPORATION
• 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: 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: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744028329 [Primary]
GS1	10816744028326 [Package]; Contains: 00816744028329; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172433

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-08

On-Brand Devices [NICO BrainPath]

• 00816744029074: 95 mm Stylet
• 00816744029050: Manipulation Tool
• 10816744028333: Sheath 11 mm x 75 mm
• 10816744028326: Sheath 11 mm x 60 mm
• 10816744028319: Sheath 11 mm x 50 mm
• 00816744028305: Sheath 13.5 mm x 95 mm
• 10816744028265: Shepherd's Hook Budde
• 10816744028258: Shepherd's Hook Sugita
• 10816744028241: Shepherd's Hook Greenberg
• 10816744028135: Sheath 13.5 mm x 75 mm
• 10816744028128: Sheath 13.5 mm x 60 mm
• 10816744028111: Sheath 13.5 mm x 50 mm
• 00816744027445: Kit - 2X 11 mm & 13.5 mm
• 00816744027438: Kit - 13.5 mm x 95 mm Upgrade
• 00816744027421: Kit - 2X 13.5 mm
• 00816744027414: Kit 13.5 mm
• 00816744027407: Kit - 2X 11 mm
• 00816744027391: Kit 11 mm
• 00816744027384: Obturator 11 mm x 75 mm
• 00816744027377: Obturator 11 mm x 60 mm
• 00816744027360: Obturator 11 mm x 50 mm
• 00816744027353: Obturator 13.5 mm x 95 mm
• 00816744027261: Obturator 13.5 mm x 50 mm (STGold)
• 00816744027193: Sterilization Tray
• 00816744027179: Obturator 13.5 mm x 75 mm
• 00816744027162: Obturator 13.5 mm x 60 mm
• 00816744027155: Obturator 13.5 mm x 50 mm
• 00816744027452: Kit - 1X 11 mm & 13.5 mm
• 00816744028428: Select Lock Shepherd's Hook - Greenberg
• 10816744038455: Navigation Probe Adapter