Ethicon
4 catalogue numbers from PRW35, listed by Provision, under Staple, Removable (Skin). 20 manufacturers in China are registered for this product code.
20manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (7), Jiangsu (6), Guangdong (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
Showing 12 of 20. All 20 manufacturers in China registered for Staple, Removable (Skin)
Record
| Listed by | Provision |
|---|---|
| FDA product code | GDT |
| Device type | Staple, Removable (Skin) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4760 |
| Premarket notification | Exempt |
| Record published | 2018-08-29 |
| Record revised | 2024-11-26 (version 3) |
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, manufacturing date |
| Distribution end date | 2024-11-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRW35 | In distribution | |
| PRR35 | In distribution | |
| PXR35 | In distribution | |
| PXW35 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| microMend PRO | Kitotech Medical Inc | 14 |
| Weck | Teleflex Medical LLC | 12 |
| 3M™ Precise™ | 3M Company | 11 |
| Proximate | Ethicon Endo-Surgery, Inc. | 6 |
| Michel Wound Clips | Sontec Instruments, Inc. | 5 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
| Multifire Premium | Covidien LP | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| microMend | Kitotech Medical Inc | 3 |
| BandGrip® Micro-Anchor® Skin Closure | Bandgrip Inc. | 2 |
| Arrow | Teleflex Medical LLC | 2 |
| SM | Covidien LP | 2 |
Showing 12 of 28. All products under Staple, Removable (Skin)
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.