Key Surgical Guidewire
Hydrophilic Guidewire, Zebra-Coated, Straight Tip, 0.025-inch Diam, 4500mm L
21manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscopic Guidewire, Gastroenterology-Urology
Record
| Listed by | Key Surgical, LLC, United States |
|---|---|
| FDA product code | OCY |
| Device type | Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-09 |
| Record revised | 2024-12-23 (version 5) |
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 |
| Storage | Storage environment atmospheric pressure 86 to 106 KiloPascal; Storage environment temperature -10 to 40 °C; Storage environment humidity 0 to 80 % RH |
| Packaging | Box of 10, case of 10 |
| Sizes | Guidewire length 2600 to 4500 mm; guidewire diameter 0.025 to 0.035 in |
| Distribution end date | 2023-11-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EN10455B | Guidewire Length 4500 mm | Withdrawn |
| EN10452B | Guidewire Length 2600 mm | Withdrawn |
| EN10450B | Guidewire Length 4500 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Single Use Urinary Guidewire | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 332 |
| Single Use Guidewire | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 194 |
| Roadrunner | Cook Incorporated | 44 |
| Cook | Cook Incorporated | 43 |
| Jagwire | Boston Scientific Corporation | 35 |
| Ercp | Heraeus Medical Components, SRL | 32 |
| Hydrophilic Guidewire for Urinary Tract | Shenzhen Hainwise Medical Technology Co., Ltd. | 24 |
| Acrobat | Cook Incorporated | 20 |
| Amplatz | Cook Incorporated | 19 |
| RevoWave™ | Piolax Medical Devices, Inc. | 19 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 18 |
| Tracer Metro | Cook Incorporated | 17 |
Showing 12 of 60. All products under Endoscopic Guidewire, Gastroenterology-Urology
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.