Trinity Sterile, Inc.
Econo Sterile Pediatric Magill Cath FCP CS25
27manufacturers in China registered for this device type
51catalogue numbers in this listing
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 | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | GEN |
| Device type | Forceps, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-25 |
| Record revised | 2024-07-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 25, pack of 50, pack of 100, pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T97-793 | In distribution | |
| T97-751 | In distribution | |
| 5080 | In distribution | |
| T98-209 | In distribution | |
| T97-778 | In distribution | |
| T98-2047 | In distribution | |
| 5072 | In distribution | |
| T98-386 | In distribution | |
| 5066 | In distribution | |
| T98-374 | In distribution | |
| T98-224 | In distribution | |
| 5059 | In distribution | |
| 5078 | In distribution | |
| 94-1924 | In distribution | |
| T98-234 | In distribution | |
| 5060 | In distribution | |
| T97-791 | In distribution | |
| T97-777 | In distribution | |
| T97-705 | In distribution | |
| T97-742 | In distribution | |
| T97-710 | In distribution | |
| 5065 | In distribution | |
| T97-748 | In distribution | |
| 5087 | In distribution | |
| 5067 | In distribution | |
| 5088 | In distribution | |
| T97-771 | In distribution | |
| T98-123 | In distribution | |
| T97-772 | In distribution | |
| T97-776 | In distribution | |
| 7128 | In distribution | |
| 96-3566A | In distribution | |
| 5077 | In distribution | |
| T98-239 | In distribution | |
| 5086 | In distribution | |
| T97-934 | In distribution | |
| 5063 | In distribution | |
| 96-3615 | In distribution | |
| T98-494 | In distribution | |
| 5079 | In distribution | |
| 7209 | In distribution | |
| T98-236 | In distribution | |
| 9200 | In distribution | |
| T98-817 | In distribution | |
| 5068 | In distribution | |
| 7039 | In distribution | |
| 7042 | In distribution | |
| T98-232 | In distribution | |
| 7024 | In distribution | |
| T97-775 | In distribution | |
| 6092 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sklar Corporation | UDI-DI | 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 245015 units |
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.