DeRoyal
NS Skin Stapler, 35 W, Fixed Head
16manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Showing 12 of 16. All 16 manufacturers in China registered for Stapler, Surgical
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | GAG |
| Device type | Stapler, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4740 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24, box of 6, case of 100, case of 30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-3002CNS | In distribution | |
| 25-3001 | In distribution | |
| 25-3002C | In distribution | |
| 25-3002 | In distribution | |
| 25-3001CNS | In distribution | |
| 25-3003 | In distribution | |
| 25-3001C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 23 |
| Medline Industries, Inc. | Medline Industries, Inc. | 12 |
| EEA | Covidien LP | 8 |
| Aeon | Lexington Medical, Inc. | 6 |
| Echelon | Ethicon Endo-Surgery, Inc. | 6 |
| easyEndoTM Lite Linear Cutting Stapler for Single Use | Ezisurg Medical Co., Ltd. | 6 |
| Echelon Linear Cutter | Ethicon Endo-Surgery, Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Ethicon | Ethicon Endo-Surgery, Inc. | 3 |
| Tri-Staple 2.0 | Covidien LP | 3 |
| GIA | Covidien LP | 3 |
| Medline | Medline Industries, Inc. | 2 |
Showing 12 of 21. All products under Stapler, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K934188 | 1994-03-28 |
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.