NICO Myriad NOVUS

GUDID 00816744027124

Console

NICO CORPORATION

Tissue morcellation system control unit

• Primary Device ID: 00816744027124
• NIH Device Record Key: af9c5153-4110-48aa-8e69-ec81703ef7b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO Myriad NOVUS
• Version Model Number: NN-7012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744027124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191599

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [NICO Myriad NOVUS]

• 00816744027124: Console
• 00816744027605: Kit - US
• 00816744027704: Kit - US Analog