Sklar Instruments
Econo Sterile Tissue FCP 1X2 5"STERILE CS/50
27manufacturers in China registered for this device type
68catalogue numbers in this listing
1recall
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 | Sklar Corporation, United States |
|---|---|
| FDA product code | GEN |
| Device type | Forceps, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-12 |
| Record revised | 2025-02-12 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 25, pack of 50, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96-2578 | In distribution | |
| 96-2533A | In distribution | |
| 96-2462 | In distribution | |
| 96-2534 | In distribution | |
| 96-2571M | In distribution | |
| 96-2575A | In distribution | |
| 96-2536M | In distribution | |
| 96-2566A | In distribution | |
| 96-2545 | In distribution | |
| 96-2555 | In distribution | |
| 96-2576 | In distribution | |
| 96-2537M | In distribution | |
| 96-2537A | In distribution | |
| 94-5034 | In distribution | |
| 96-2533 | In distribution | |
| 96-2563M | In distribution | |
| 96-2215A | In distribution | |
| 96-2539A | In distribution | |
| 96-2670M | In distribution | |
| 94-6616 | In distribution | |
| 96-2551A | In distribution | |
| 96-2563 | In distribution | |
| 96-2544 | In distribution | |
| 96-2551 | In distribution | |
| 96-2412A | In distribution | |
| 96-2573M | In distribution | |
| 96-2670 | In distribution | |
| 96-2450M | In distribution | |
| 96-2579 | In distribution | |
| 96-2410 | In distribution | |
| 96-2573A | In distribution | |
| 96-2921 | In distribution | |
| 96-2569 | In distribution | |
| 96-2556 | In distribution | |
| 96-2550 | In distribution | |
| 96-2554 | In distribution | |
| 96-2573 | In distribution | |
| 96-2596 | In distribution | |
| 96-2560 | In distribution | |
| 96-2533M | In distribution | |
| 96-2538 | In distribution | |
| 96-2579M | In distribution | |
| 96-2557 | In distribution | |
| 96-2570 | In distribution | |
| 96-2561 | In distribution | |
| 96-2537 | In distribution | |
| 96-2568 | In distribution | |
| 96-2549 | In distribution | |
| 96-2568A | In distribution | |
| 96-2563A | In distribution | |
| 96-2569A | In distribution | |
| 96-2572 | In distribution | |
| 96-2552 | In distribution | |
| 96-2660 | In distribution | |
| 96-2575 | In distribution | |
| 96-2412M | In distribution | |
| 96-2688 | In distribution | |
| 96-2539M | In distribution | |
| 96-2532 | In distribution | |
| 96-2561A | In distribution | |
| 96-2553 | In distribution | |
| 94-6146 | In distribution | |
| 96-2536 | In distribution | |
| 96-2412 | In distribution | |
| 94-0290 | In distribution | |
| 96-2548 | In distribution | |
| 96-2534A | In distribution | |
| 96-2535A | 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.