SkyVac

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name: SkyVac FDA UDI
Generic Name: Surgical plume evacuation system filter FDA UDI
Device Name: 8 hour filter for Skytron Smoke Evacuation System Models SES-P/K Ergon 1 FDA UDI
Model / Reference: SES1 FDA UDI
Description: 8 hour filter for Skytron Smoke Evacuation System Models SES-P/K Ergon 1 FDA UDI

Identifiers

Catalog Number: SES1 FDA UDI
Primary DI / UDI-DI: 10841736100940 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

Category: Surgical plume evacuation system filter

SkyVac 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.

Surgimedics® — COASTAL LIFE TECHNOLOGIES, INC. · Class II
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 458defc0-6333-440e-9ee0-87cd6b2e813c 35 fields · synced May 30, 2026