Gyrus Acmi

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: GYRUS ACMI FDA UDI
Generic Name: ENT shaver system FDA UDI
Device Name: DIEGO IRRIGATION TUBE SET FOR USE WITH VIPER HANDPIECES 12' (3.66 m) LENGTH FDA UDI
Model / Reference: 70336900 FDA UDI
Description: DIEGO IRRIGATION TUBE SET FOR USE WITH VIPER HANDPIECES 12' (3.66 m) LENGTH FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925040519 FDA UDI
510(k) Number: K020594 FDA UDI
FDA Product Code: ERL FDA UDI
GMDN Term: ENT shaver system 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

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

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

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Also classified as ENT shaver system.

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Gyrus ACMI — Provision · Class I
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Medtronic — Provision · Class I
Gyrus ACMI — Provision · Class I

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

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 6a6777f2-f239-4928-ba93-2a76076bce5d 34 fields · synced Jun 1, 2026