Sklar®
Gynecological instrument used for performing pelvic examinations.
8manufacturers in China registered for this device type
115catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| 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 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Shanghai Dynamic Medical Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 37 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-20 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|---|
| 90-3841 | In distribution | ||
| 90-3804 | In distribution | ||
| 21-303 | 12 | In distribution | |
| 90-3960 | In distribution | ||
| 90-3752C | In distribution | ||
| 90-3871 | In distribution | ||
| 90-3875 | In distribution | ||
| 96-2998M | 25 | In distribution | |
| 96-2607 | 25 | In distribution | |
| 90-3713 | In distribution | ||
| 90-3765 | In distribution | ||
| 90-3959 | In distribution | ||
| 96-2381 | 25 | In distribution | |
| 21-362 | 12 | In distribution | |
| 90-3559C | In distribution | ||
| 90-3705 | In distribution | ||
| 90-3833 | In distribution | ||
| 90-3700C | In distribution | ||
| 90-3944 | In distribution | ||
| 96-2372 | 25 | In distribution | |
| 90-3851 | In distribution | ||
| 90-3865 | In distribution | ||
| 90-3810 | In distribution | ||
| 90-3701C | In distribution | ||
| 90-3761 | In distribution | ||
| 90-3560 | In distribution | ||
| 90-3837 | In distribution | ||
| 90-2741 | In distribution | ||
| 90-3702C | In distribution | ||
| 90-3711 | In distribution | ||
| 90-3751 | In distribution | ||
| 90-3955 | In distribution | ||
| 90-3555 | In distribution | ||
| 96-3005M | 25 | In distribution | |
| 90-3802C | In distribution | ||
| 90-3808 | In distribution | ||
| 90-3702 | In distribution | ||
| 90-3849C | In distribution | ||
| 90-3060 | In distribution | ||
| 90-3050 | In distribution | ||
| 90-3713C | In distribution | ||
| 90-3720 | In distribution | ||
| 90-3802 | In distribution | ||
| 21-322 | 12 | In distribution | |
| 96-2381M | 25 | In distribution | |
| 90-3952 | In distribution | ||
| 96-2377M | 25 | In distribution | |
| 90-3061 | In distribution | ||
| 90-3803 | In distribution | ||
| 90-3835 | In distribution | ||
| 90-3722 | In distribution | ||
| 90-3712 | In distribution | ||
| 96-3003M | 25 | In distribution | |
| 90-3712C | In distribution | ||
| 90-3800 | In distribution | ||
| 90-3710 | In distribution | ||
| 90-3943 | In distribution | ||
| 21-324 | 12 | In distribution | |
| 90-3946 | In distribution | ||
| 90-3849 | In distribution | ||
| 90-3706 | In distribution | ||
| 90-3558 | In distribution | ||
| 96-2999M | 25 | In distribution | |
| 90-3755 | In distribution | ||
| 90-3872 | In distribution | ||
| 90-3711C | In distribution | ||
| 90-3732 | In distribution | ||
| 21-313 | 12 | In distribution | |
| 90-3710C | In distribution | ||
| 96-2379M | 25 | In distribution | |
| 90-3839 | In distribution | ||
| 90-3730 | In distribution | ||
| 90-3558C | In distribution | ||
| 90-3873 | In distribution | ||
| 90-3750 | In distribution | ||
| 90-3874 | In distribution | ||
| 96-3001 | 50 | In distribution | |
| 90-3876 | In distribution | ||
| 90-3763 | In distribution | ||
| 90-3814 | In distribution | ||
| 90-3762 | In distribution | ||
| 90-3559 | In distribution | ||
| 90-3851C | In distribution | ||
| 90-3751C | In distribution | ||
| 90-3954 | In distribution | ||
| 90-3912 | In distribution | ||
| 96-2373M | 25 | In distribution | |
| 96-2375M | 25 | In distribution | |
| 90-3701 | In distribution | ||
| 90-3945 | In distribution | ||
| 90-3803C | In distribution | ||
| 90-3950 | In distribution | ||
| 90-3754 | In distribution | ||
| 96-3005 | 25 | In distribution | |
| 90-3766 | In distribution | ||
| 90-3767 | In distribution | ||
| 90-3750C | In distribution | ||
| 90-3731 | In distribution | ||
| 90-3957 | In distribution | ||
| 90-3740 | In distribution | ||
| 21-334 | 12 | In distribution | |
| 90-3721 | In distribution | ||
| 90-3753 | In distribution | ||
| 90-3806 | In distribution | ||
| 90-3951 | In distribution | ||
| 90-3752 | In distribution | ||
| 90-3812 | In distribution | ||
| 21-348 | 12 | In distribution | |
| 90-3700 | In distribution | ||
| 21-337 | 12 | In distribution | |
| 90-3953 | In distribution | ||
| 96-2371M | 25 | In distribution | |
| 21-368 | 12 | In distribution | |
| 90-3913 | In distribution | ||
| 90-3815 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed Incorporated | Elmed, Inc. | 481 |
| Millennium | Avalign Technologies, Inc. | 226 |
| Hayden Medical | Hayden Medical Inc | 219 |
| Marina Medical | Marina Medical Instruments, Inc. | 190 |
| Elmed | Elmed, Inc. | 178 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 108 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 105 |
| Aesculap | Aesculap AG | 102 |
| BR Surgical, LLC | BR Surgical LLC | 94 |
| Ambler Surgical | Ambler Surgical, LLC | 92 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 92 |
| Gynex | Gynex Corporation | 91 |
Showing 12 of 255. All products under Speculum, Vaginal, Metal
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. | 475 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.