Dilator, Catheter
Amplatz Type Graduated Renal Dilatation Set
7manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Tianjin (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | GCC |
| Device type | Dilator, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-11-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0062601000 | 8 F Diameter | In distribution |
| M0062601090 | 24 F Diameter | In distribution |
| M0062601110 | 28 F Diameter | In distribution |
| M0062601030 | 4.1 mm Diameter | In distribution |
| M001481540 | 20 cm Effective Length | In distribution |
| M0062601010 | 8 F Diameter | In distribution |
| M0062601120 | 30 F Diameter | In distribution |
| M0062601040 | 4.7 mm Diameter | In distribution |
| M0062601070 | 35 cm Length | In distribution |
| M0062601080 | 7.4 mm Diameter | In distribution |
| M0062601100 | 8.7 mm Diameter | In distribution |
| M0062601050 | 35 cm Length | In distribution |
| M001482520 | 14 F Diameter | In distribution |
| M0062601060 | 18 F Diameter | In distribution |
| M0062601020 | 3.4 mm Diameter | In distribution |
| M001482500 | 10 F Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HNM Medical | HNM Stainless, LLC. | 111 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Surgipros | Surgipros LLC | 13 |
| Byrd | Cook Vandergrift Inc. | 11 |
| Percutaneous Nephrostomy Dilator | Well Lead Medical Co., Ltd. | 8 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 7 |
| Novo Surgical | Novo Surgical, Inc. | 7 |
| Screw Dilator | Argon Medical Devices, Inc. | 7 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 2 |
| Cook | Cook Incorporated | 2 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 1 |
Showing 12 of 16. All products under Dilator, Catheter
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.