← Back to catalogue

Megadyne

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0028

by Megadyne Medical Products, Inc.

Identity

Trade Name
Megadyne EUDAMEDFDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Bayonet, 6 inch (15.2 cm) FDA UDI
Model / Reference
0028 EUDAMEDFDA UDI
Description
E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Bayonet, 6 inch (15.2 cm) FDA UDI

Identifiers

Catalog Number
0028 FDA UDI
Primary DI / UDI-DI
D-USMF000017046000062S9 EUDAMED
10614559100455 FDA UDI
Basic UDI-DI
B-USMF000017046000062S9 EUDAMED
510(k) Number
K081791 FDA UDI
K862221 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
K0201010801 OPEN ELECTROSURGERY NEEDLES, SINGLE-USE EUDAMED
GMDN Term
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
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

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

Cleared under the same submission

K081791 also covers:

K862221 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Megadyne Medical Products, Inc.

Sources (2)

  • FDA UDI b0130a39-e2d0-45f4-bc9b-59054f4f7763 37 fields · synced Oct 6, 2026
  • EUDAMED 4e893cf8-4b7a-41a0-9f73-8e8d22600949 61 fields · synced Jul 30, 2026