Romeo 2 PAD Instrumentation
Catalogue number SPE-IN 00 72-N, listed by Spineart SA, Switzerland, under Forceps, General & Plastic Surgery. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (7), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Tiansong Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 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 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 27. All 27 manufacturers in China registered for Forceps, General & Plastic Surgery
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | GEN |
| Device type | Forceps, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-31 |
| Record revised | 2019-08-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPE-IN 00 72-N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 2,052 |
| Surtex | Surtex Instruments Ltd | 1,613 |
| Millennium | Avalign Technologies, Inc. | 1,238 |
| Ambler Surgical | Ambler Surgical, LLC | 1,163 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 1,020 |
| Surgical Direct | Surgical Direct, Inc. | 857 |
| Novo Surgical | Novo Surgical, Inc. | 603 |
| Peak Medical | Peak Medical Distribution Inc | 598 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 598 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 582 |
| Forceps | KLS-Martin L.P. | 577 |
| Boss Instruments | Boss Instruments, Ltd. | 543 |
Showing 12 of 751. All products under Forceps, General & Plastic Surgery
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.