Capio
Catalogue number M0068311250, listed by Boston Scientific Corporation, United States, under Holder, Needle, Gastroenterologic. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FHQ |
| Device type | Holder, Needle, Gastroenterologic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2020-12-04 (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 |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0068311250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EMI Super Micro Needle Holder | EMI Factory Co., Ltd. | 432 |
| Surgical Direct | Surgical Direct, Inc. | 422 |
| Peak Medical | Peak Medical Distribution Inc | 406 |
| Novo Surgical | Novo Surgical, Inc. | 312 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 293 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 235 |
| HNM Medical | HNM Stainless, LLC. | 225 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 211 |
| Scanlan® Needle Holders | Scanlan International, Inc. | 192 |
| Hayden Medical | Hayden Medical Inc | 191 |
| Jacobson Needle Holder | Sontec Instruments, Inc. | 173 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 164 |
Showing 12 of 455. All products under Holder, Needle, Gastroenterologic
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 |
|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2018-02-12 | Class II | Device Design | Potential for Capio sutures to break and /or detach. | 21,051 | 2020-04-10 |
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.