V. Mueller
V. Mueller GRAVES SPECULUM WITH SUCTION LARGE, BLUE RF COATED FOR ELECTROSURGERY BLADE LENGTH 4-1/2 inches X 1-3/8 inches
8manufacturers in China registered for this device type
55catalogue 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 | Steris Corporation, United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-08-17 |
| Record revised | 2024-08-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GA32 | In distribution | |
| BE3188 | In distribution | |
| GL10 | In distribution | |
| GL259 | In distribution | |
| GA11 | In distribution | |
| GL200 | In distribution | |
| GL250 | In distribution | |
| GL475 | In distribution | |
| GL210 | In distribution | |
| GA259 | In distribution | |
| GL464 | In distribution | |
| GL301 | In distribution | |
| GA17 | In distribution | |
| GA25 | In distribution | |
| GL260 | In distribution | |
| GL18 | In distribution | |
| LS11 | In distribution | |
| GL570 | In distribution | |
| GL300 | In distribution | |
| GA10 | In distribution | |
| GL469 | In distribution | |
| GL55 | In distribution | |
| GL220 | In distribution | |
| GL11 | In distribution | |
| GL20 | In distribution | |
| GL15 | In distribution | |
| GA18 | In distribution | |
| GL12 | In distribution | |
| GA12 | In distribution | |
| GL750 | In distribution | |
| GL302 | In distribution | |
| GL465 | In distribution | |
| GL14 | In distribution | |
| GL486 | In distribution | |
| GA30 | In distribution | |
| GL463 | In distribution | |
| GL462 | In distribution | |
| GL30 | In distribution | |
| GL460 | In distribution | |
| GL31 | In distribution | |
| GL16 | In distribution | |
| GL40 | In distribution | |
| GL42 | In distribution | |
| GL470 | In distribution | |
| GL25 | In distribution | |
| GL461 | In distribution | |
| GL34 | In distribution | |
| GA258 | In distribution | |
| GL33 | In distribution | |
| GL17 | In distribution | |
| GL466 | In distribution | |
| GA31 | In distribution | |
| GL32 | In distribution | |
| GL258 | In distribution | |
| GL467 | 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 |
| Ambler Surgical | Ambler Surgical, LLC | 92 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 92 |
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 |
|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | UDI-DI | 2023-03-16 | Class II | Labeling mix-ups | A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products. | 726 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.