Sunoptic Technologies

FDA UDI

Class II (US FDA UDI)

by Sunoptic Technologies

Identity

Trade Name: Sunoptic Technologies FDA UDI
Generic Name: Open surgical site internal light FDA UDI
Device Name: LED Rover Disoposable, Non-Sterile Series FDA UDI
Model / Reference: Rover Lightsource series FDA UDI
Description: LED Rover Disoposable, Non-Sterile Series FDA UDI

Identifiers

Primary DI / UDI-DI: M678SLS0 FDA UDI
FDA Product Code: FCW FDA UDI
FTD FDA UDI
GMDN Term: Open surgical site internal light FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.4580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Category: Open surgical site internal light

Sunoptic Technologies by Sunoptic Technologies — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Sunoptic Technologies

Sources (1)

FDA UDI ec60aad5-70f8-42ed-bbae-b85c9e9eaf06 35 fields · synced Jun 8, 2026