Skytron

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name: Skytron FDA UDI
Generic Name: Surgical plume evacuation system filter FDA UDI
Device Name: 35 Hour filter for Skytron Smoke Evacuation System Models Smoke-E-Vac Ergon 3 FDA UDI
Model / Reference: AIR SAFE FDA UDI
Description: 35 Hour filter for Skytron Smoke Evacuation System Models Smoke-E-Vac Ergon 3 FDA UDI

Identifiers

Catalog Number: AIR SAFE FDA UDI
Primary DI / UDI-DI: 10841736100933 FDA UDI
FDA Product Code: FYD FDA UDI
GMDN Term: Surgical plume evacuation system filter 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 9.5 Millimeter FDA UDI
Outer Diameter — 0.25 Inch FDA UDI
Outer Diameter — 0.875 Inch FDA UDI
Outer Diameter — 22 Millimeter FDA UDI
Outer Diameter — 6.4 Millimeter FDA UDI
Outer Diameter — 0.375 Inch FDA UDI

Category: Surgical plume evacuation system filter

Skytron by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical plume evacuation system filter.

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Geiger Odor Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
VIROSAFE — Conmed Corporation · Class II
Geiger Smoke Evacuator Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
CONMED — Conmed Corporation · Class II
Neptune — Stryker Corp. · Class II
VIROSAFE — Conmed Corporation · Class II
Geiger Smoke Evacuator Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II

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 89bcfa30-59a5-4cb0-bba4-40ebc075686f 36 fields · synced May 30, 2026