M-Catch
Standard Retrieval Net, 3x6cm, 230cm
19manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (5), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
Showing 12 of 19. All 19 manufacturers in China registered for Snare, Non-Electrical
Record
| Listed by | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FGX |
| Device type | Snare, Non-Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-06 |
| Record revised | 2021-04-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Case of 5 |
| Sizes | Width 3 cm; depth 6 cm; length 160 to 350 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1175-01 | Width 3 cm | In distribution |
| 1175-00 | Length 160 cm | In distribution |
| 1175-02 | Length 350 cm | In distribution |
| 1175-10 | Width 3 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Snare, Non-Electrical | Hangzhou AGS MedTech Co., Ltd. | 262 |
| Disposable Cold Snares | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 8 |
| Disposable Polypectomy Cold Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 6 |
| RotoNet | Endo-Therapeutics, Inc. | 6 |
| SwirlNet | Endo-Therapeutics, Inc. | 6 |
| Lasso | Diversatek Healthcare Inc | 4 |
| Snare | Taewoongmedical.co., Ltd. | 4 |
| Optimos™ Snare | Taewoongmedical.co., Ltd. | 4 |
| EnTrap(TM) Polyp Retrieval Snare Net | Micro-Tech (Nanjing) Co., Ltd. | 4 |
| Polypectomy Snare | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 3 |
| Exacto | Us Endoscopy | 3 |
| Exacto Mundo | Us Endoscopy | 3 |
Showing 12 of 20. All products under Snare, Non-Electrical
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Diversatek Healthcare Inc | UDI-DI | 2021-10-29 | Class II | Employee error | M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct. | 245 devices | 2024-04-10 |
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.