Ambler Surgical
O'Sullivan-O'Connor self-retaining vaginal speculum, complete set includes: frame, 2 lateral blades, and 3 center blades - 5/8'' x 1 3/4'', 1 1/2'' x 3 1/3'', and 1 3/4'' x 3 1/2''
8manufacturers in China registered for this device type
92catalogue numbers in this listing
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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Graves view-more vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Graves view-more vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Leep Graves vaginal speculum | In distribution | |
| Leep Graves view-more vaginal speculum | In distribution | |
| Leep Graves maxi-view vaginal speculum | In distribution | |
| Leep Graves vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Leep Weisman-Pederson vaginal speculum | In distribution | |
| DeVilbiss vaginal speculum | In distribution | |
| DeVilbiss vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Leep Graves maxi-view vaginal speculum | In distribution | |
| DeVilbiss vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Kogan endocervical speculum | In distribution | |
| Kristeller vaginal speculum | In distribution | |
| Steiner-Auvard vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Leep Weisman-Graves vaginal speculum | In distribution | |
| Leep Graves view-more vaginal speculum | In distribution | |
| Steiner-Auvard vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Leep Graves vaginal speculum | In distribution | |
| Leep Weisman-Pederson vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Kristeller vaginal speculum | In distribution | |
| Leep Pederson maxi-view vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Graves view-more vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Kogan endocervical speculum | In distribution | |
| Leep Weisman-Pederson vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Graves view-more vaginal speculum | In distribution | |
| Graves view-more vaginal speculum | In distribution | |
| Kristeller vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Leep Weisman-Graves vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Kristeller vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Leep Pederson maxi-view vaginal speculum | In distribution | |
| Leep Graves view-more vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| O’Sullivan-O’Connor self-retaining vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Huffman-Graves vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Pederson vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Leep Pederson vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Leep Weisman-Pederson vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Cusco vaginal speculum | In distribution | |
| Weisman-Pederson vaginal speculum | In distribution | |
| Auvard vaginal speculum | In distribution | |
| Leep Weisman-Pederson vaginal speculum | In distribution | |
| Weisman-Graves vaginal speculum | In distribution | |
| Graves vaginal speculum | In distribution | |
| Graves view-more vaginal speculum | In distribution | |
| Garrigue vaginal speculum | In distribution | |
| Leep Graves vaginal speculum | In distribution | |
| Leep Graves vaginal speculum | 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 |
| Sklar® | Sklar Corporation | 115 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 108 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 105 |
| Aesculap | Aesculap AG | 102 |
| BR Surgical, LLC | BR Surgical LLC | 94 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 92 |
| Gynex | Gynex Corporation | 91 |
Showing 12 of 255. All products under Speculum, Vaginal, Metal
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.