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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
Tympanotomy knife, single-use FDA UDI
Device Name
DISPOSABLE MYRINGOTOMY BLADE WITH SPEAR TIP ANGLED SHAFT FDA UDI
Model / Reference
70130794 FDA UDI
Description
DISPOSABLE MYRINGOTOMY BLADE WITH SPEAR TIP ANGLED SHAFT FDA UDI

Identifiers

Primary DI / UDI-DI
00821925040373 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tympanotomy knife, 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: Tympanotomy knife, 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 Tympanotomy knife, 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 1564e895-61a4-454a-a931-380bd3c705cd 33 fields · synced May 30, 2026