Zutron Medical
Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vented Bag,…
Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vented Bag, Transport Tote, Suction Tubing with Scallop Connectors
2manufacturers in China registered for this device type
80catalogue 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 | Zutron Medical, L.L.C. |
|---|---|
| FDA product code | NWU |
| Device type | Endoscope Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2023-07-28 |
| Record revised | 2024-04-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 25, case of 20, case of 100, case of 50, case of 30, case of 35 |
| Distribution end date | 2024-04-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Endoscopy Procedure Kit | Withdrawn | ||
| Endoscopy Procedure Kit | 50 | Withdrawn | |
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| Endoscopy Procedure Kit | 100 | Withdrawn | |
| Endoscopy Procedure Kit | Withdrawn | ||
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| Endoscopy Procedure Kit | 100 | Withdrawn | |
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| Endoscopy Procedure Kit | 100 | Withdrawn | |
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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 |
| Medical Action Industries | Medical Action Industries, Inc. | 54 |
| Essential Kit | Medivators Inc | 44 |
| Preclean Kit | Medivators Inc | 31 |
| 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.