NICO Myriad-LX

GUDID 00816744026813

Replacement Bulb & Filters

NICO CORPORATION

General-purpose light source

• Primary Device ID: 00816744026813
• NIH Device Record Key: 0a4b0047-8f76-4788-9db3-8ab76477a1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO Myriad-LX
• Version Model Number: NN-9010
• 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

Customer Support Contacts

• Phone: 317-660-7118
• Email: info@NICOneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744026813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191599

FDA Product Code

• FSS: Light, Surgical, Floor Standing

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [NICO Myriad-LX]

• 00816744027131: Light Source
• 00816744021016: Illumination Pack - 13 Gauge
• 00816744021009: Illumination Pack - 11 Gauge
• 00816744026813: Replacement Bulb & Filters
• 00816744027643: Light Source - Analog