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Gyrus ACMI

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Medium-wave diathermy treatment system electrode, active FDA UDI
Device Name
Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units FDA UDI
Model / Reference
UCA FDA UDI
Description
Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units FDA UDI

Identifiers

Primary DI / UDI-DI
00821925008045 FDA UDI
510(k) Number
K914883 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Medium-wave diathermy treatment system electrode, active FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medium-wave diathermy treatment system electrode, active

Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medium-wave diathermy treatment system electrode, active.

Cleared under the same submission

K914883 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 15cf08f3-c9d4-480c-9d27-b67ddbd63561 34 fields · synced Jun 8, 2026