NICO BrainPath

GUDID 00816744027353

Obturator 13.5 mm x 95 mm

NICO CORPORATION

Neurosurgical retraction obturator

• Primary Device ID: 00816744027353
• NIH Device Record Key: ae87d2d2-86fe-42ad-a61b-e1f9f0fc9557
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO BrainPath
• Version Model Number: NN-7035
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 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
• Phone: 317-660-7118
• Email: info@NICOneuro.com
• Phone: 317-660-7118
• Email: info@NICOneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744027353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172433

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00816744027353]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-27

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