NICO TRIOwand

GUDID 10816744028289

Handpiece 14 cm

NICO CORPORATION

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 10816744028289
• NIH Device Record Key: c733467f-1297-4336-b1ed-14124f979bb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICO TRIOwand
• Version Model Number: NN-8028
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816744028282 [Primary]
GS1	10816744028289 [Package]; Contains: 00816744028282; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162075

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2016-09-14

Devices Manufactured by NICO CORPORATION

• 00816744027483 - NICO Myriad SPECTRA: 2024-04-09 Myriad SPECTRA Foot Pedal
• 00816744027537 - NICO Myriad SPECTRA: 2024-04-09 NICO Myriad SPECTRA Light Source - US
• 00816744027704 - NICO Myriad NOVUS: 2023-05-08 Kit - US Analog
• 00816744027643 - NICO Myriad-LX: 2023-05-04 Light Source - Analog
• 00816744023003 - NICO BrainPath Approach: 2021-04-13 BP & Illumination Pack [11x50 mm + PB1313 + SelectLock(G) + meniG + SecureH] + [13GA Illum]
• 00816744023010 - NICO BrainPath Approach: 2021-04-13 BP & Illumination Pack [11x60 mm + PB1313 + SelectLock(G) + meniG + SecureH] + [13GA Illum]
• 00816744023027 - NICO BrainPath Approach: 2021-04-13 BP & Illumination Pack [11x75 mm + PB1313 + SelectLock(G)B + meniG + SecureH] + [13GA Illum]
• 00816744023034 - NICO BrainPath Approach: 2021-04-13 BP & Illumination Pack [13.5x50 mm + PB1313 SelectLock(G) + meniG + SecureH] + [13GA Illum]