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Diego

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
DIEGO FDA UDI
Generic Name
Electrosurgical handpiece, reusable FDA UDI
Device Name
DIEGO PK CONSOLE FDA UDI
Model / Reference
70339050 FDA UDI
Description
DIEGO PK CONSOLE FDA UDI

Identifiers

Primary DI / UDI-DI
00821925011427 FDA UDI
510(k) Number
K034004 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Electrosurgical handpiece, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical handpiece, reusable

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

Similar devices

Also classified as Electrosurgical handpiece, reusable.

Cleared under the same submission

K034004 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 f430cf84-f46a-4497-9e63-ac1e8c6ff55a 34 fields · synced Jun 8, 2026