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Gyrus Acmi

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
GYRUS ACMI FDA UDI
Generic Name
Surgical irrigation/aspiration handpiece, single-use FDA UDI
Device Name
EAR SUCTION NEEDLE 18 GAUGE DISPOSABLE FDA UDI
Model / Reference
130722 FDA UDI
Description
EAR SUCTION NEEDLE 18 GAUGE DISPOSABLE FDA UDI

Identifiers

Primary DI / UDI-DI
00821925034099 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Surgical irrigation/aspiration handpiece, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical irrigation/aspiration handpiece, 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 Surgical irrigation/aspiration handpiece, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI d44932ba-42a2-4719-8f07-f08a9f2a06bc 33 fields · synced May 30, 2026