BladeNeedleSYSTEM
The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count…
The Qlicksmart BladeNeedleSYSTEM is two safety devices in one → the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles.
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 | Qlicksmart PTY., Ltd., Australia |
|---|---|
| FDA product code | GAB |
| Device type | Needle, Suturing, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-11-27 |
| Record revised | 2019-12-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Storage | Special storage condition: Keep dry and avoid direct exposure to sunlight |
| Packaging | Outer carton of 4, carton of 144, inner box of 30, outer cartopn of 4 |
| Distribution end date | 2019-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| QBNS202S-R | 30 | In distribution | |
| QBNS202S-R | In distribution | ||
| QBNS202B-R | In distribution | ||
| QBNS202B-R | 144 | In distribution | |
| QBNS202S-R | 30 | In distribution | |
| QBNS202B | Withdrawn | ||
| QBNS202S | Withdrawn |
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.