Henry Schein
Disposable Skin Stapler 35R Regular Sterile
16manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | GAG |
| Device type | Stapler, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4740 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 50 to 80 % RH; Special storage condition: with no erosive gas |
| Packaging | Dispenser box of 5, case of 20 |
| Sizes | Length 5.9 to 7.2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9009734 | Length 5.9 mm | In distribution |
| 5702956 | In distribution | |
| 9007010 | Length 7.2 mm | In distribution |
| 5702957 | 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 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| 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 |
| 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
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.