BR Surgical, LLC
Quad-Blade Lateral Vaginal Speculum, 4-way lateral expander, large, LEEP blue coated, with smoke extractor, 1" x 4 1/2"
8manufacturers in China registered for this device type
94catalogue 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 | BR Surgical LLC, 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 | 2024-03-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR71-12152 | In distribution | |
| BR70-36124 | In distribution | |
| BR71-12051 | In distribution | |
| BR70-12502 | In distribution | |
| BR71-11022 | In distribution | |
| BR70-11122 | In distribution | |
| BR70-12004 | In distribution | |
| BR70-28103 | In distribution | |
| BR71-11058 | In distribution | |
| BR71-12053 | In distribution | |
| BR70-12011 | In distribution | |
| BR70-36424 | In distribution | |
| BR70-12002 | In distribution | |
| BR70-12603 | In distribution | |
| BR71-11051 | In distribution | |
| BR71-11502 | In distribution | |
| BR71-11124 | In distribution | |
| BR70-12021 | In distribution | |
| BR70-14003 | In distribution | |
| BR70-12503 | In distribution | |
| BR71-12153 | In distribution | |
| BR71-11055 | In distribution | |
| BR70-29100 | In distribution | |
| BR70-29102 | In distribution | |
| BR70-12012 | In distribution | |
| BR70-29101 | In distribution | |
| BR70-27101 | In distribution | |
| BR71-11053 | In distribution | |
| BR70-12023 | In distribution | |
| BR70-11603 | In distribution | |
| BR71-11703 | In distribution | |
| BR71-11513 | In distribution | |
| BR70-11124 | In distribution | |
| BR70-12005 | In distribution | |
| BR71-11023 | In distribution | |
| BR70-11001 | In distribution | |
| BR70-11002 | In distribution | |
| BR70-10026 | In distribution | |
| BR70-10046 | In distribution | |
| BR70-11006 | In distribution | |
| BR71-11052 | In distribution | |
| FG70-12001 | In distribution | |
| BR70-12002XN | In distribution | |
| BR71-12512 | In distribution | |
| BR70-30600 | In distribution | |
| BR71-11125 | In distribution | |
| BR70-12024 | In distribution | |
| BR70-11000 | In distribution | |
| BR71-12052 | In distribution | |
| WG70-12002 | In distribution | |
| FG70-11004 | In distribution | |
| BR70-11501 | In distribution | |
| BR70-11004 | In distribution | |
| FG70-12002 | In distribution | |
| WG70-11023 | In distribution | |
| BR70-11602 | In distribution | |
| BR70-13002 | In distribution | |
| BR70-11125 | In distribution | |
| BR70-11024 | In distribution | |
| WG70-11022 | In distribution | |
| BR70-11021 | In distribution | |
| BR71-11054 | In distribution | |
| BR70-12602 | In distribution | |
| BR70-10045 | In distribution | |
| BR70-30384 | In distribution | |
| BR70-36324 | In distribution | |
| BR70-11502 | In distribution | |
| BR70-11003 | In distribution | |
| BR71-30383 | In distribution | |
| BR71-11512 | In distribution | |
| BR70-13003 | In distribution | |
| BR70-11025 | In distribution | |
| BR70-11022 | In distribution | |
| BR71-11122 | In distribution | |
| BR70-13001 | In distribution | |
| BR70-36524 | In distribution | |
| BR71-12055 | In distribution | |
| BR70-12000 | In distribution | |
| BR71-12151 | In distribution | |
| BR70-36024 | In distribution | |
| BR71-11503 | In distribution | |
| BR70-10001 | In distribution | |
| BR71-30925 | In distribution | |
| BR70-12022 | In distribution | |
| BR70-12003 | In distribution | |
| BR70-27102 | In distribution | |
| BR71-36024 | In distribution | |
| BR70-30383 | In distribution | |
| BR71-12054 | In distribution | |
| BR70-11503 | In distribution | |
| BR71-11702 | In distribution | |
| BR70-12001 | In distribution | |
| BR70-11023 | In distribution | |
| BR70-28101 | 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 |
| 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
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.