Prepzyme (1 Gallon RB38)
Catalogue number 34559-27, listed by Ruhof Corporation, under Cleaner, Ultrasonic, Medical Instrument. 48 manufacturers in China are registered for this product code.
48manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (26), Zhejiang (7), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Xiamen Atyou Health Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
Showing 12 of 48. All 48 manufacturers in China registered for Cleaner, Ultrasonic, Medical Instrument
Record
| Listed by | Ruhof Corporation |
|---|---|
| FDA product code | FLG |
| Device type | Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6150 |
| Premarket notification | Exempt |
| Record published | 2025-06-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 40 to 130 °F; Storage environment temperature 40 to 130 °F |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 34559-27 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 49 |
| Prolystica | Steris Corporation | 41 |
| Ultra Clean Systems | Getinge Disinfection AB | 33 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Steelco | Steelco SPA | 16 |
| BrandMax Tri-Clean | Brandmax | 12 |
| Alconox | Alconox, LLC | 11 |
| Valsure | Steris Corporation | 11 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| Detojet | Alconox, LLC | 9 |
| Liquinox | Alconox, LLC | 8 |
| Citranox | Alconox, LLC | 8 |
Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument
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.