← Back to catalogue

Nico

FDA UDI

Class II (US FDA UDI)

by Sunoptic Technologies

Identity

Trade Name
NICO FDA UDI
Generic Name
Procedural cold light bulb FDA UDI
Device Name
Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A FDA UDI
Model / Reference
NN-9010 FDA UDI
Description
Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A FDA UDI

Identifiers

Catalog Number
NN-9010 FDA UDI
Primary DI / UDI-DI
M678NN90100 FDA UDI
FDA Product Code
FSS FDA UDI
GMDN Term
Procedural cold light bulb FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Procedural cold light bulb

Nico by Sunoptic Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Procedural cold light bulb.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sunoptic Technologies

Sources (1)

  • FDA UDI 316b33e9-4c2b-4ed9-aab4-b6ab454a69a7 34 fields · synced May 30, 2026