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Gyrus Acmi, Inc

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
GYRUS ACMI, INC FDA UDI
Generic Name
ENT speculum holder FDA UDI
Device Name
SPECULUM HOLDER WITH SCHUKNECHT MODIFICATION FDA UDI
Model / Reference
130072 FDA UDI
Description
SPECULUM HOLDER WITH SCHUKNECHT MODIFICATION FDA UDI

Identifiers

Primary DI / UDI-DI
00821925011670 FDA UDI
FDA Product Code
JYK FDA UDI
GMDN Term
ENT speculum holder 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT speculum holder

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

Similar devices

Also classified as ENT speculum holder.

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 00e803a3-b406-4e04-a4c4-fea7c6f1204a 33 fields · synced May 30, 2026