Sklar®
Wachenfeldt Appl/Remov X-ACT 5
9manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | GDO |
| Device type | Applier, Surgical, Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-09 |
| Record revised | 2020-07-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 24-1450 | In distribution | ||
| 24-1116 | 100 | In distribution | |
| 24-1121 | In distribution | ||
| 24-1250 | In distribution | ||
| 24-1150 | In distribution | ||
| 24-2155 | In distribution | ||
| 24-2047 | In distribution | ||
| 24-1120 | In distribution | ||
| 24-1650 | In distribution | ||
| 24-2055 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 996 |
| Teleflex | Teleflex Medical LLC | 61 |
| Aesculap | Aesculap AG | 46 |
| Ligaclip | Ethicon Endo-Surgery, Inc. | 29 |
| Surgical Direct | Surgical Direct, Inc. | 28 |
| Elmed | Elmed, Inc. | 23 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 19 |
| Europclip | Ackermann Instrumente Gmbh | 17 |
| Lazic | Peter Lazic Gmbh | 15 |
| Artisential Clip Applier Large | LivsMed Inc. | 14 |
| Artisential Clip Applier Medium Large | LivsMed Inc. | 14 |
Showing 12 of 73. All products under Applier, Surgical, Clip
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.