Gyrus ACMI

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Gyrus ACMI FDA UDI
Generic Name: Ear wick, non-biodegradable FDA UDI
Device Name: Blu Ear Packing, with drawstring,12 mm x 15 mm, Bacteriostatic FDA UDI
Model / Reference: 7089-0860 FDA UDI
Description: Blu Ear Packing, with drawstring,12 mm x 15 mm, Bacteriostatic FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925037427 FDA UDI
FDA Product Code: KCN FDA UDI
GMDN Term: Ear wick, non-biodegradable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.5220 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ear wick, non-biodegradable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 0585657e-4d30-473b-8e65-7dd6e6b83713 33 fields · synced May 30, 2026