TRACLUX

Basic Information

• Brand Name: TRACLUX
• Primary DI: M678TLC0
• Version / Model: TLC
• Catalog Number: TLC2575, TLC25150, TLC1353-U
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Labeler DUNS: 094586898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-05
• Public Version: 3
• Public Version Date: 2023-05-26
• Public Version Status: Update
• Public Device Record Key: 268bdd8c-efad-4d18-9ff3-83706df9e392

Device Description

TRACLUX Light Carrier, Sterile, Single Use, and accessories

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65349	Open surgical site internal light	An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M678TLC0	HIBCC
Package	M678TLC1	HIBCC		5	In Commercial Distribution
Package	M678TLC3	HIBCC		20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]