Integra® Miltex®
Integra® Miltex® Surgeon Needle, 1/2 circle, cut edge #20
21manufacturers in China registered for this device type
71catalogue numbers in this listing
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 | Integra LifeSciences Production Corporation, 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 |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-05-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MS192-1 | 12 | In distribution | |
| MS192-20 | 12 | In distribution | |
| MS141-8 | 12 | In distribution | |
| MS140-10 | 12 | In distribution | |
| MS192-7 | 12 | In distribution | |
| MS141-10 | 12 | In distribution | |
| MS140A-16 | 12 | In distribution | |
| MS192A-12 | 12 | In distribution | |
| MS140A-9 | 12 | In distribution | |
| MS140-20 | 12 | In distribution | |
| MS140A-10 | 12 | In distribution | |
| MS140A-14 | 12 | In distribution | |
| MS140-13 | 12 | In distribution | |
| MS140-3 | 12 | In distribution | |
| MS192-19 | 12 | In distribution | |
| MS192-6 | 12 | In distribution | |
| MS192A-18 | 12 | In distribution | |
| MS140-15 | 12 | In distribution | |
| MS192-9 | 12 | In distribution | |
| MS192-18 | 12 | In distribution | |
| MS140-4 | 12 | In distribution | |
| MS192A-8 | 12 | In distribution | |
| MS140A-12 | 12 | In distribution | |
| MS140-17 | 12 | In distribution | |
| MS192-10 | 12 | In distribution | |
| MS140-11 | 12 | In distribution | |
| MS140A-18 | 12 | In distribution | |
| MS192-8 | 12 | In distribution | |
| MS155-2 | 12 | In distribution | |
| MS192A-10 | 12 | In distribution | |
| MS140A-17 | 12 | In distribution | |
| MS140A-13 | 12 | In distribution | |
| MS192A-16 | 12 | In distribution | |
| MS140-7 | 12 | In distribution | |
| MS140A-11 | 12 | In distribution | |
| MS192-12 | 12 | In distribution | |
| MS141-6 | 12 | In distribution | |
| MS140-12 | 12 | In distribution | |
| MS140A-1 | 12 | In distribution | |
| MS192-11 | 12 | In distribution | |
| MS192A-14 | 12 | In distribution | |
| MS192-16 | 12 | In distribution | |
| MS192-17 | 12 | In distribution | |
| MS192-13 | 12 | In distribution | |
| MS140-18 | 12 | In distribution | |
| MS140-14 | 12 | In distribution | |
| MS140-6 | 12 | In distribution | |
| MS192-3 | 12 | In distribution | |
| MS140A-15 | 12 | In distribution | |
| MS140-1 | 12 | In distribution | |
| MS140-5 | 12 | In distribution | |
| MS141-9 | 12 | In distribution | |
| MS140A-20 | 12 | In distribution | |
| MS140A-2 | 12 | In distribution | |
| MS140A-7 | 12 | In distribution | |
| MS192-14 | 12 | In distribution | |
| MS192-2 | 12 | In distribution | |
| MS192-15 | 12 | In distribution | |
| MS140A-8 | 12 | In distribution | |
| MS192-5 | 12 | In distribution | |
| MS140-9 | 12 | In distribution | |
| MS140A-6 | 12 | In distribution | |
| MS140-8 | 12 | In distribution | |
| MS141-7 | 12 | In distribution | |
| MS140-19 | 12 | In distribution | |
| MS140-2 | 12 | In distribution | |
| MS140-16 | 12 | In distribution | |
| MS192-4 | 12 | In distribution | |
| MS172-3 | 12 | Withdrawn | |
| MS192-0 | 12 | Withdrawn | |
| MS126-16 | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Richard-Allan® Needle 1/2 Circle Taper | Aspen Surgical Products, Inc. | 86 |
| 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 |
| Medline Industries, Inc. | Medline Industries, 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.