Preclean Kit
Preclean Plus Kit includes Brush, DEFENDO Air/Water Suction Biopsy, Air Water Jet Valve Kit, and Endo Carry-on Transport Pad
2manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
Record
| Listed by | Medivators Inc, United States |
|---|---|
| FDA product code | NWU |
| Device type | Endoscope Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-01-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4000896 | In distribution | |
| 4000899 | In distribution | |
| 4000898 | In distribution | |
| 4000906 | In distribution | |
| 4000905 | In distribution | |
| 4000892 | In distribution | |
| 4000907 | In distribution | |
| 4000900 | In distribution | |
| 4001127 | In distribution | |
| 4000909 | In distribution | |
| 4000891 | In distribution | |
| 4000890 | In distribution | |
| 4000910 | In distribution | |
| 4001126 | In distribution | |
| 4001125 | In distribution | |
| 4000893 | In distribution | |
| 4000911 | In distribution | |
| 4000904 | In distribution | |
| 4001957 | In distribution | |
| 4000901 | In distribution | |
| 4000902 | In distribution | |
| 4000894 | In distribution | |
| 4001123 | In distribution | |
| 4000903 | In distribution | |
| 4000908 | In distribution | |
| 4001139 | In distribution | |
| 4000895 | In distribution | |
| 4001124 | In distribution | |
| 4001128 | In distribution | |
| 4002040 | In distribution | |
| 4000897 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10,257 |
| Endo Carry-on Procedure Kit | Medivators Inc | 1,777 |
| Custom Procedure KIT | Medivators Inc | 573 |
| VIA | Us Endoscopy | 519 |
| ACS | American Contract Systems, Inc. | 416 |
| Medline Industries, Inc. | Medline Industries, Inc. | 337 |
| Zutron Medical | Zutron Medical, L.L.C. | 80 |
| Medical Action Industries | Medical Action Industries, Inc. | 54 |
| Essential Kit | Medivators Inc | 44 |
| VIA procedure kit – custom | Us Endoscopy | 29 |
| Endo Carry-on Custom Procedure Kit | Medivators Inc | 23 |
| Merit Medical® | Merit Medical Systems, Inc. | 17 |
Showing 12 of 23. All products under Endoscope Introducer Kit
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.