Sklar®
Censitrac Ready Lateral Vaginal Retractor
8manufacturers in China registered for this device type
72catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| 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 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HDL |
| Device type | Retractor, Vaginal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98-364 | In distribution | |
| 90-9180 | In distribution | |
| 91-5180 | In distribution | |
| 91-5185 | In distribution | |
| 90-9000 | In distribution | |
| 98-324 | In distribution | |
| 98-366 | In distribution | |
| 91-5082 | In distribution | |
| 91-5022 | In distribution | |
| 91-5034 | In distribution | |
| 91-5010 | In distribution | |
| 91-5084 | In distribution | |
| 91-5154 | In distribution | |
| 91-5092 | In distribution | |
| 91-5060 | In distribution | |
| 90-3995 | In distribution | |
| 90-3980C | In distribution | |
| 91-5038 | In distribution | |
| 91-5150 | In distribution | |
| 98-303 | In distribution | |
| 90-3983 | In distribution | |
| 91-5086 | In distribution | |
| 95-303 | In distribution | |
| 95-322 | In distribution | |
| 91-5130 | In distribution | |
| 90-9004 | In distribution | |
| 98-368 | In distribution | |
| 91-5036 | In distribution | |
| 91-5152 | In distribution | |
| 98-362 | In distribution | |
| 91-5088 | In distribution | |
| 98-336 | In distribution | |
| 91-5050 | In distribution | |
| 90-3994 | In distribution | |
| 91-5040 | In distribution | |
| 91-5062 | In distribution | |
| 91-5042 | In distribution | |
| 91-5162 | In distribution | |
| 90-9100 | In distribution | |
| 95-362 | In distribution | |
| 90-9103 | In distribution | |
| 95-347 | In distribution | |
| 95-304 | In distribution | |
| 90-3997 | In distribution | |
| 91-5120 | In distribution | |
| 91-5029 | In distribution | |
| 91-5048 | In distribution | |
| 91-5018 | In distribution | |
| 91-5064 | In distribution | |
| 91-5012 | In distribution | |
| 91-5142 | In distribution | |
| 98-348 | In distribution | |
| 98-334 | In distribution | |
| 91-5132 | In distribution | |
| 91-5014 | In distribution | |
| 95-334 | In distribution | |
| 91-5024 | In distribution | |
| 90-3990 | In distribution | |
| 90-3980 | In distribution | |
| 98-325 | In distribution | |
| 90-9002 | In distribution | |
| 91-5047 | In distribution | |
| 90-3982 | In distribution | |
| 90-9102 | In distribution | |
| 91-5068 | In distribution | |
| 91-5020 | In distribution | |
| 95-324 | In distribution | |
| 98-312 | In distribution | |
| 95-312 | In distribution | |
| 90-3998 | In distribution | |
| 90-3996 | In distribution | |
| 95-348 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 60 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| HNM Medical | HNM Stainless, LLC. | 52 |
| Elmed Incorporated | Elmed, Inc. | 48 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 43 |
| Aesculap | Aesculap AG | 38 |
| Surgical Direct | Surgical Direct, Inc. | 27 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 25 |
| Pilling | Teleflex Medical LLC | 25 |
| V. Mueller | Steris Corporation | 22 |
| Boss Instruments | Boss Instruments, Ltd. | 22 |
Showing 12 of 59. All products under Retractor, Vaginal
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. | 40 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.