Winged Guidewire Introducer Needle
Winged Guidewire Introducer Needle 18ga x 7cm
9manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K974745 |
| Record published | 2016-09-20 |
| Record revised | 2026-05-11 (version 11) |
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 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BGWI1802 | 18ga x 7cm | In distribution |
| BGWI1902 | 19ga x 7cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 107 |
| Trocar | Doppkon Gmbh & Co. KG | 53 |
| Merit Advance® | Merit Medical Systems, Inc. | 39 |
| HeartSpan® | Merit Medical | 29 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 22 |
| Argyle | Cardinal Health | 20 |
| Apple-Hunt Secondary Cannula | Coopersurgical, Inc. | 20 |
| HeartSpan® | Merit Medical Systems, Inc. | 16 |
| AngioDynamics | AngioDynamics, Inc. | 16 |
| Majestik® | Merit Medical Systems, Inc. | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
Showing 12 of 57. All products under Trocar
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medical Device Technologies, Inc. | 510(k) number | 2009-09-01 | Not classified | Other | Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilizat | 5,675 | 2011-02-25 |
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.