Wavicide-01

Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.

Registry build 21.09.26
1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MED
Manufacturer City Province Registered as Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for Wavicide-01
Listed by Medical Chemical Corporation, United States
FDA product code MED
Device type Sterilant, Medical Devices
Device class Class 2
Regulation 21 CFR 880.6885
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
510(k) K914749
Record published 2016-09-20
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 15 to 30 °C; Special storage condition: Do Not Freeze
Packaging Box of 12, box of 4

Catalogue Numbers

Catalogue numbers for Wavicide-01
Catalogue number Size Status
0104-1gl IRI In distribution
0104-55gl In distribution
0104-250gl In distribution
0112-32oz In distribution
0104-1gl In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Cidex™ Advanced Sterilization Products Services Inc. 8
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Bimanual I/A Systems Sterimedix Ltd. 7

Showing 12 of 96. All products under Sterilant, Medical Devices

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