Versipass Suture Passer Needle
Suture passer needle for the Versipass Suture Passer
21manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Guangdong Huilin Packaging Technology Group Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
Showing 12 of 21. All 21 manufacturers in China registered for Needle, Suturing, Disposable
Record
| Listed by | Lincotek Medical, LLC, United States |
|---|---|
| FDA product code | GAB |
| Device type | Needle, Suturing, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-10-17 |
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 |
| Storage | Special storage condition: Store in a cool, dry place |
| Packaging | Pack of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4727 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Richard-Allan® Needle 1/2 Circle Taper | Aspen Surgical Products, Inc. | 86 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 71 |
| Richard-Allan® Needle 1/2 Circle Reverse Cutting | Aspen Surgical Products, Inc. | 61 |
| Devon | Cardinal Health 200, LLC | 60 |
| Devon | Cardinal Health | 54 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 44 |
| Richard-Allan® Needle 3/8 Circle Reverse Cutting | Aspen Surgical Products, Inc. | 26 |
| Richard-Allan® Dispos-A-PAK | Aspen Surgical Products, Inc. | 24 |
| Richard-Allan® Needle 3/8 Circle Trocar | Aspen Surgical Products, Inc. | 12 |
| Richard-Allan® Needle Straight Cutting | Aspen Surgical Products, Inc. | 11 |
| Key Surgical Needle Counters | Key Surgical, LLC | 11 |
| Richard-Allan® Needle Straight Taper | Aspen Surgical Products, Inc. | 10 |
Showing 12 of 198. All products under Needle, Suturing, Disposable
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.