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 bipolar distal suction, SERRATED DIEGO ELITE FDA UDI
Model / Reference: BB4000SS FDA UDI
Description: SHAVER BLADE, 4 MM, 0 DEGREES bipolar distal suction, SERRATED DIEGO ELITE FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925038134 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

Similar devices

Also classified as ENT shaver system.

Stryker — Provision · Class I
Karl Storz — Provision · Class I
Gyrus ACMI — Provision · Class I
UNIDRIVE — Karl Storz GmbH & Co. KG · Class II
Gyrus ACMI — Provision · Class I
Medtronic — Provision · Class I
Medtronic — Provision · Class I
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

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

Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI ade150d8-6393-43f4-addb-3e2cf62db5ab 34 fields · synced May 30, 2026