GUS

G18-E Gus countertop station

Registry build 21.09.26
1manufacturer
10catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PHT
Manufacturer City Province Registered as Device types
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105

Record

Regulatory record for GUS
Listed by Civco Medical Instruments Co., Inc., United States
FDA product code PHT
Device type Basin For Endoscope Reprocessing
Device class Class 1
Regulation 21 CFR 876.1500
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-01-27
Record revised 2023-04-04 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for GUS
Catalogue number Size Status
610-850 In distribution
610-921 In distribution
610-2168 In distribution
610-2159 In distribution
610-720 In distribution
610-2165 In distribution
610-2163 In distribution
610-2174 In distribution
610-2144 In distribution
610-2173 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
BR Surgical, LLC BR Surgical LLC 26
CeroFrict SML MED-Tech Solutions Limited 5
Basin For Endoscope Reprocessing Richard Wolf Gmbh 3
Revital-Ox Steris Corporation 2
Soaking Cup Civco Medical Instruments Co., Inc. 2
Disinfecting Container Civco Medical Instruments Co., Inc. 1
ECO EZ Cleanse Meditech Endoscopy Ltd 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer