Diego Elite

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: DIEGO ELITE FDA UDI
Generic Name: ENT shaver system FDA UDI
Device Name: SHAVER BLADE, 4 MM, 0 DEGREES monopolar distal suction, SERRATED DIEGO ELITE FDA UDI
Model / Reference: MB4000SS FDA UDI
Description: SHAVER BLADE, 4 MM, 0 DEGREES monopolar distal suction, SERRATED DIEGO ELITE FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925038431 FDA UDI
510(k) Number: K123429 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: ENT shaver system 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: ENT shaver system

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

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Gyrus ACMI — Provision · Class I

Cleared under the same submission

K123429 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI ab33a5b8-dbdb-46a4-b54b-5d2a8ad5823d 34 fields · synced May 30, 2026