Sklar
Censitrac Ready Fehland Intestinal Clamp 10 Inches
16manufacturers in China registered for this device type
79catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Suzhou Hengxiang IMP. & EXP. Co., Ltd. | Suzhou | Jiangsu | Exporter | 35 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Acmed Import & Export Co., Ltd. | Suzhou | Jiangsu | Exporter | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Showing 12 of 16. All 16 manufacturers in China registered for Clamp, Surgical, General & Plastic Surgery
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | GDJ |
| Device type | Clamp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-03-13 |
| Record revised | 2019-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 97-655 | In distribution | ||
| 47-2930C | In distribution | ||
| 33-1090 | In distribution | ||
| 36-1602 | In distribution | ||
| 33-1190C | In distribution | ||
| 47-3050 | In distribution | ||
| 95-606 | In distribution | ||
| 21-606 | 12 | In distribution | |
| 33-1377 | In distribution | ||
| 47-2852 | In distribution | ||
| 47-2852C | In distribution | ||
| 40-2839 | In distribution | ||
| 47-2932 | In distribution | ||
| 47-3040 | In distribution | ||
| 97-629 | In distribution | ||
| 47-2962 | In distribution | ||
| 21-611 | 12 | In distribution | |
| 97-601 | In distribution | ||
| 33-1181 | In distribution | ||
| 47-2940 | In distribution | ||
| 97-606 | In distribution | ||
| 97-623 | In distribution | ||
| 47-2935C | In distribution | ||
| 95-629 | In distribution | ||
| 47-2947 | In distribution | ||
| 40-1781 | In distribution | ||
| 40-2928 | In distribution | ||
| 36-7020C | In distribution | ||
| 47-2930 | In distribution | ||
| 40-2273 | In distribution | ||
| 40-2660 | In distribution | ||
| 47-3047 | In distribution | ||
| 47-2935 | In distribution | ||
| 33-1097 | In distribution | ||
| 33-1098 | In distribution | ||
| 47-2960 | In distribution | ||
| 33-1096 | In distribution | ||
| 33-1099 | In distribution | ||
| 33-1180 | In distribution | ||
| 47-2960C | In distribution | ||
| 47-3050C | In distribution | ||
| 33-1376 | In distribution | ||
| 40-6930 | In distribution | ||
| 33-1375 | In distribution | ||
| 47-3060C | In distribution | ||
| 40-2927 | In distribution | ||
| 95-635 | In distribution | ||
| 33-1090C | In distribution | ||
| 96-5655 | 50 | In distribution | |
| 96-2929 | 100 | In distribution | |
| 21-635 | 12 | In distribution | |
| 47-2927 | In distribution | ||
| 21-655 | 12 | In distribution | |
| 36-7020 | In distribution | ||
| 40-2838 | In distribution | ||
| 47-3057C | In distribution | ||
| 33-1190 | In distribution | ||
| 97-635 | In distribution | ||
| 47-2941 | In distribution | ||
| 47-2957 | In distribution | ||
| 47-2837 | In distribution | ||
| 40-1782 | In distribution | ||
| 47-2835 | In distribution | ||
| 47-3060 | In distribution | ||
| 40-2922 | In distribution | ||
| 47-2837C | In distribution | ||
| 40-2274 | In distribution | ||
| 47-3040C | In distribution | ||
| 96-2632M | 25 | In distribution | |
| 47-2937 | In distribution | ||
| 95-655 | In distribution | ||
| 40-1780 | In distribution | ||
| 40-2923 | In distribution | ||
| 40-2921 | In distribution | ||
| 21-629 | 12 | In distribution | |
| 33-1290 | In distribution | ||
| 47-3057 | In distribution | ||
| 40-2655 | In distribution | ||
| 40-2925 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 666 |
| Millennium | Avalign Technologies, Inc. | 131 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 127 |
| Aesculap | Aesculap AG | 92 |
| Hayden Medical | Hayden Medical Inc | 73 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 73 |
| Boss Instruments | Boss Instruments, Ltd. | 66 |
| Stille Hemostats | Stille AB | 66 |
| Novo Surgical | Novo Surgical, Inc. | 64 |
| Clamp, Surgical, General & Plastic Surgery | George Tiemann & Co. | 59 |
| Clamp | KLS-Martin L.P. | 59 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 55 |
Showing 12 of 208. All products under Clamp, Surgical, General & Plastic Surgery
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 300 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.