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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
ACE Blade, E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 6.5 inch, 16.5 cm, Modified Extended Insulation, Single-Use FDA UDI
Model / Reference
ACE14M FDA UDI
Description
ACE Blade, E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 6.5 inch, 16.5 cm, Modified Extended Insulation, Single-Use FDA UDI

Identifiers

Primary DI / UDI-DI
10614559103234 FDA UDI
510(k) Number
K081791 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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
Ethylene Oxide 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

K081791 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 (1)

  • FDA UDI b89bb644-e6d6-4725-8c82-9c85c2d20a3b 37 fields · synced Jun 9, 2026