Megadyne

FDA UDI

Class II (US FDA UDI)

by Megadyne Medical Products, Inc.

Identity

Trade Name: Megadyne FDA UDI
Generic Name: Surgical plume evacuation system FDA UDI
Device Name: MEGADYNE TES RF Sensor Cable FDA UDI
Model / Reference: 2255JTES FDA UDI
Description: MEGADYNE TES RF Sensor Cable FDA UDI

Identifiers

Catalog Number: 2255JTES FDA UDI
Primary DI / UDI-DI: 20705036046520 FDA UDI
510(k) Number: K200250 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

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

Megadyne by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K200250 also covers:

MEGADYNE — Megadyne Medical Products, Inc.

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: Megadyne Medical Products, Inc.

Sources (1)

FDA UDI e24e743b-04b1-4b41-b386-32969c9fb07f 37 fields · synced Jun 9, 2026