NICO Myriad SPECTRA

GUDID 00816744027476

Myriad SPECTRA Console

NICO CORPORATION

Tissue morcellation system control unit

• Primary Device ID: 00816744027476
• NIH Device Record Key: 034e4e26-95aa-4488-a6a3-1aff230f08e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO Myriad SPECTRA
• Version Model Number: NN-7047
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744027476 [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: 2024-06-05
• Device Publish Date: 2024-05-28

On-Brand Devices [NICO Myriad SPECTRA]

• 00816744027537: NICO Myriad SPECTRA Light Source - US
• 00816744027483: Myriad SPECTRA Foot Pedal
• 00816744027476: Myriad SPECTRA Console
• 00816744027728: Kit - US