Diego

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: DIEGO FDA UDI
Generic Name: ENT shaver system handpiece FDA UDI
Device Name: 70339001R REFURBISHED DIEGO HANDPIECE FDA UDI
Model / Reference: 70339001R FDA UDI
Description: 70339001R REFURBISHED DIEGO HANDPIECE FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925026582 FDA UDI
510(k) Number: K020594 FDA UDI
FDA Product Code: ERL FDA UDI
GMDN Term: ENT shaver system handpiece 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

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: ENT shaver system handpiece

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

Similar devices

Also classified as ENT shaver system handpiece.

PolypVac® — Laurimed, LLC · Class II
PELLO — Stryker Corp. · Class II
S120 Shaver + Cable — Bien-Air Surgery SA · Class II
S120 Shaver — Bien-Air Surgery SA · Class II
Shaver System — Stryker Corp. · Class II
PolypVac® — Laurimed, LLC · Class II

Cleared under the same submission

K020594 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 222d5710-e512-4b3a-8363-7643b43fa75a 34 fields · synced May 30, 2026