Primary Device ID | 00855373008043 |
NIH Device Record Key | 18e2b319-19c1-4611-8372-1a4e1fa84f43 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NICO Corporation |
Version Model Number | STX0350 |
Catalog Number | NN-9010 |
Company DUNS | 094586898 |
Company Name | SUNOPTIC TECHNOLOGIES LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855373008043 [Primary] |
FSS | Light, Surgical, Floor Standing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-11 |
Device Publish Date | 2025-06-03 |
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00855373008043 - NICO Corporation | 2025-06-11 Replacement 300-Watt Xenon Lamp Module for NICO Myriad-LX Light Source, Part Number NN-7064 |
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M678NN70640 - NICO Myriad-LX | 2025-04-04 300-watt Xenon Light Source, Analog |
M678NN90100 - NICO | 2025-04-04 Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A |
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M678ROVER0 - Sunoptic Technologies | 2024-08-14 Rover lightsource series |
M678SLS10 - Sunoptic Technologies | 2024-08-14 LED Rover Disoposable, Non-Sterile Series |