TracLux

Basic Information

• Brand Name: TracLux
• Primary DI: M678TLS0
• Version / Model: TLS2575, TLS25150
• Catalog Number: TLS2550, TLS25150
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Labeler DUNS: 094586898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-08
• Public Version: 1
• Public Version Date: 2025-05-16
• Public Version Status: New
• Public Device Record Key: 48a4374c-06d2-4bcf-bcfc-5a63b7e21166

Device Description

TracLux HandLite Retractor System, Retractor Handle and Retractor Blade kitted TLS2550 consist of one retractor handle (TLH001) and one retractor blade TLB2550 (25mm x 75mm) TLS25150 consist of one retractor handle (TLH001) and one retractor blade TLB25150 (25mm x 150mm) Retractor blades and retractor handle components are direct marked with the UDI-DI number M678HHR0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M678TLS0	HIBCC

Customer Contacts

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