Megadyne

FDA UDI

Class II (US FDA UDI)

by Megadyne Medical Products, Inc.

Identity

Trade Name: Megadyne FDA UDI
Generic Name: Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name: E-Z Clean Electrosurgical L-Wire Hook Laparoscopic Electrode for use with All-In-One Suction Irrigation Pencil, 5mm x 32cm, Single-Use FDA UDI
Model / Reference: 0063 FDA UDI
Description: E-Z Clean Electrosurgical L-Wire Hook Laparoscopic Electrode for use with All-In-One Suction Irrigation Pencil, 5mm x 32cm, Single-Use FDA UDI

Identifiers

Primary DI / UDI-DI: 10614559100561 FDA UDI
510(k) Number: K922002 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Endoscopic electrosurgical electrode, monopolar, single-use 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

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

Cleared under the same submission

K922002 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 432bc77f-cf59-4222-8ade-60876b85419c 37 fields · synced Jun 9, 2026