Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

FDA UDI

Class II (US FDA UDI)

by Sunoptic Technologies

Identity

Trade Name: Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer FDA UDI
Generic Name: Open surgical site internal light FDA UDI
Device Name: Battery powered light source for illumination of a surgical field. FDA UDI
Model / Reference: ROVER SLS FDA UDI
Description: Battery powered light source for illumination of a surgical field. FDA UDI

Identifiers

Catalog Number: ROVER SLS-S FDA UDI
Primary DI / UDI-DI: M678SLSS0 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open surgical site internal light

Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer 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 ddf1c94f-b6f6-41c6-a38d-f8e37f7feb81 35 fields · synced Jun 6, 2026