AccessGUDID - DEVICE: NICO (M678NN90100)

GUDID

Device Identifier (DI) Information

Brand Name: NICO
Version or Model: NN-9010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NN-9010
Company Name: SUNOPTIC TECHNOLOGIES LLC

Primary DI Number: M678NN90100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094586898 *Terms of Use

Device Description: Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65951	Procedural cold light bulb	An electrically-powered device in the form of a light bulb designed to be integrated into an appropriate light source unit (not included) to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during surgery, examination, and/or endoscopy. It is a replaceable component of the assembly and does not include a light switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSS	Light, Surgical, Floor Standing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 316b33e9-4c2b-4ed9-aab4-b6ab454a69a7
Public Version Date: April 04, 2025
Public Version Number: 1
DI Record Publish Date: March 27, 2025