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Megadyne

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0605

by Megadyne Medical Products, Inc.

Identity

Trade Name
Megadyne EUDAMEDFDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Wire, Single-Use, Tip Only, for use with Reusable Indicator Shaft FDA UDI
Model / Reference
0605 EUDAMEDFDA UDI
Description
E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Wire, Single-Use, Tip Only, for use with Reusable Indicator Shaft FDA UDI

Identifiers

Primary DI / UDI-DI
D-USMF000017046000131S3 EUDAMED
10614559101858 FDA UDI
Basic UDI-DI
B-USMF000017046000131S3 EUDAMED
510(k) Number
K943055 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

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

Cleared under the same submission

K943055 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Megadyne Medical Products, Inc.

Sources (2)

  • FDA UDI 87c408c7-dfa2-4ed4-b064-bccb52f6703c 37 fields · synced Oct 6, 2026
  • EUDAMED 999f20a7-fccc-4324-8a56-43278e27f315 61 fields · synced Jul 10, 2026