Megadyne

FDA UDI

Class II (US FDA UDI)

by Megadyne Medical Products, Inc.

Identity

Trade Name: Megadyne FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Curved Spatula, 38 cm., Reusable, For Use With Foot Control Pedal FDA UDI
Model / Reference: 3018SA FDA UDI
Description: Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Curved Spatula, 38 cm., Reusable, For Use With Foot Control Pedal FDA UDI

Identifiers

Primary DI / UDI-DI: 10614559102206 FDA UDI
510(k) Number: K040699 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: Not 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

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

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 99a4237a-491f-4153-a658-44b5a3c9877c 37 fields · synced Jun 9, 2026