TracLux

FDA UDI

Class I (US FDA UDI)

by Sunoptic Technologies

Identity

Trade Name: TracLux FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: 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 FDA UDI
Model / Reference: TLS2575, TLS25150 FDA UDI
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 FDA UDI

Identifiers

Catalog Number: TLS2550, TLS25150 FDA UDI
Primary DI / UDI-DI: M678TLS0 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable

TracLux by Sunoptic Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sunoptic Technologies

Sources (1)

FDA UDI 48a4374c-06d2-4bcf-bcfc-5a63b7e21166 35 fields · synced Jun 1, 2026