Gyrus Acmi

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: GYRUS ACMI FDA UDI
Generic Name: Metal/carbide ENT bur, reusable FDA UDI
Device Name: STAPES DIAMOND BURR 1.7MM DIAMETER STAINLESS STEEL (NON-STERILE) FDA UDI
Model / Reference: 70326128 FDA UDI
Description: STAPES DIAMOND BURR 1.7MM DIAMETER STAINLESS STEEL (NON-STERILE) FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925021938 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Metal/carbide ENT bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4140 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Metal/carbide ENT bur, reusable

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

Similar devices

Also classified as Metal/carbide ENT bur, reusable.

Tungst.Carb.Burr, Ø1.4x70mm, 50k — Bien-Air Surgery SA · Class I
Bur PM2-70 50K Steel Ø4.0 — Bien-Air Surgery SA · Class I
Bur PM2-70 50K Carb Ø0.5 — Bien-Air Surgery SA · Class I
Oto-Flex — MEDTRONIC XOMED, INC. · Class II
Bur PM2-70 50K Carb Ø6.0 — Bien-Air Surgery SA · Class I
Tungst.Carb.Burr, Ø0.5x70mm, 50k — Bien-Air Surgery SA · Class I
FENTEX — FENTEX medical GmbH · Class I
Bur PM2-70 50K Carb Xcut Ø6.0 — Bien-Air Surgery SA · 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

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 47f9751a-04ce-41dd-84ef-aee175215d1e 33 fields · synced May 31, 2026