Coloplast
11 catalogue numbers from AE1138, listed by Coloplast A/S, Denmark, under Endoscopic Guidewire, Gastroenterology-Urology. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Coloplast A/S, Denmark |
|---|---|
| FDA product code | OCY |
| Device type | Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-19 |
| Record revised | 2024-12-23 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Packaging | Retail box of 5, shipper box of 30, shipper box of 24, shipper box of 18 |
| Sizes | Length 80 to 150 cm; outer diameter 0.032 to 0.038 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE1138 | Length 80 cm | In distribution |
| AE0A32 | Outer Diameter 0.032 in | In distribution |
| AE0035 | Outer Diameter 0.035 in | In distribution |
| AE0D35 | Length 150 cm | In distribution |
| AE0E32 | Length 90 cm | In distribution |
| AE0038 | Outer Diameter 0.038 in | In distribution |
| AE0C35 | Length 150 cm | In distribution |
| AE0A38 | Outer Diameter 0.038 in | In distribution |
| AE0032 | Outer Diameter 0.032 in | In distribution |
| AE0E38 | Length 90 cm | In distribution |
| AE0A35 | Outer Diameter 0.035 in | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150927 | 2015-05-27 |
| K131072 | 2013-07-09 |
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.