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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
Endoscope cleaning brush access adaptor FDA UDI
Device Name
Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel 3 Fr, 65 CM (2/PK) FDA UDI
Model / Reference
CB-365 FDA UDI
Description
Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel 3 Fr, 65 CM (2/PK) FDA UDI

Identifiers

Primary DI / UDI-DI
00821925038295 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Endoscope cleaning brush access adaptor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 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: Endoscope cleaning brush access adaptor

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

Similar devices

Also classified as Endoscope cleaning brush access adaptor.

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 f8c68b01-1bd5-49ba-ac8f-58c9d390913a 33 fields · synced May 30, 2026