Gyrus Acmi

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: GYRUS ACMI FDA UDI
Generic Name: Ear speculum, single-use FDA UDI
Device Name: EAR SPECULUM CHILD, 3 MM DISPOSABLE FDA UDI
Model / Reference: 130698 FDA UDI
Description: EAR SPECULUM CHILD, 3 MM DISPOSABLE FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925033283 FDA UDI
FDA Product Code: EPY FDA UDI
GMDN Term: Ear speculum, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ear speculum, single-use

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

Similar devices

Also classified as Ear speculum, single-use.

JEDMED — JEDMED Instrument Company · Class I
KaWe — Medical, Inc. · Class I
JEDMED — JEDMED Instrument Company · Class I
OtoSight Speculum Tip Combination Package — Photonicare, Inc. · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I
CFM Technologies — C F M TECHNOLOGIES INC · Class I
CFM Technologies — C F M TECHNOLOGIES INC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I

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

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

Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI de38ee87-4171-4f5a-bcf5-a563dfc31250 33 fields · synced May 30, 2026