Skytron Smoke Evacuation

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name: Skytron Smoke Evacuation FDA UDI
Generic Name: Surgical plume evacuation system FDA UDI
Device Name: Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately. FDA UDI
Model / Reference: ELVV220 FDA UDI
Description: Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately. FDA UDI

Identifiers

Primary DI / UDI-DI: 10841736114992 FDA UDI
FDA Product Code: FYD FDA UDI
GMDN Term: Surgical plume evacuation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5070 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical plume evacuation system

Skytron Smoke Evacuation by Skytron, LLC — 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: Skytron, LLC

Sources (1)

FDA UDI 2ab24388-3755-4ceb-807e-6341258d2947 34 fields · synced May 30, 2026