Screw Dilator
Screw Dilator 14F x 25cm
7manufacturers in China registered for this device type
7catalogue 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 | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | GCC |
| Device type | Dilator, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K990808 |
| Record published | 2016-09-12 |
| Record revised | 2026-05-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Distribution end date | 2025-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 631438025 | 14F x 25cm | Withdrawn |
| 631038025 | 10F x 25cm | Withdrawn |
| 630938025 | 9F x 25cm | Withdrawn |
| 631647025 | 16F x 25cm | Withdrawn |
| 631238025 | 12F x 25cm | Withdrawn |
| 630738025 | 7Fr x 25cm | Withdrawn |
| 630838025 | 8F x 25cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HNM Medical | HNM Stainless, LLC. | 111 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Dilator, Catheter | Boston Scientific Corporation | 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 |
| 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.