Soleil

FDA UDI

Class II (US FDA UDI)

by Benco Dental Supply Co.

Identity

Trade Name: SOLEIL FDA UDI
Generic Name: Cable/lead/sensor/probe cover, non-sterile FDA UDI
Device Name: SOLEIL SUPREME LED SLEEVE 250 FDA UDI
Model / Reference: 4950-145 FDA UDI
Description: SOLEIL SUPREME LED SLEEVE 250 FDA UDI

Identifiers

Primary DI / UDI-DI: 00366975010810 FDA UDI
FDA Product Code: PEM FDA UDI
GMDN Term: Cable/lead/sensor/probe cover, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 2.36 Inch FDA UDI
Length — 10.39 Inch FDA UDI

Category: Cable/lead/sensor/probe cover, non-sterile

Soleil by Benco Dental Supply Co. — 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: Benco Dental Supply Co.

Sources (1)

FDA UDI c01c8d14-8117-4a3e-8d1c-5ad4c426617b 34 fields · synced Jun 1, 2026