Elmed
Standard Graves Vaginal Speculums - Medium Large Insulated Graves Wide View VU-MAX Vaginal Speculum With 2-3/4" Square Yoke 4-3/4 X 1-1/2' With Permanent Smoke Evacuation Tube
8manufacturers in China registered for this device type
178catalogue 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 | Elmed, Inc., United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-09 |
| Record revised | 2024-11-07 (version 2) |
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, manufacturing date, serial number |
| Distribution end date | 2024-11-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-10-13-IM | In distribution | |
| 32-19-402-IM | In distribution | |
| 32-10-04-IV | In distribution | |
| 32-19-401-IM | In distribution | |
| 32-19-411-IV | In distribution | |
| 32-22-603-EV | In distribution | |
| 32-11-12A | In distribution | |
| 32-12-12A | In distribution | |
| 32-10-02E | In distribution | |
| 51-MNS | In distribution | |
| 32-10-12-E | In distribution | |
| 32-10-14-I | In distribution | |
| ST3219411IV | In distribution | |
| 32-10-12-I | In distribution | |
| 32-24-25-I | In distribution | |
| 32-22-10 | In distribution | |
| 32-16-03-I | In distribution | |
| ST321005IM | In distribution | |
| 32-12-11-EV | In distribution | |
| 32-10-03-IV | In distribution | |
| 32-12-03-E | In distribution | |
| 32-10-13-EV | In distribution | |
| ST321211I | In distribution | |
| 32-12-11-E | In distribution | |
| 32-10-01E | In distribution | |
| ST321012 | In distribution | |
| ST321014A | In distribution | |
| 32-12-13 | In distribution | |
| 32-10-03-EV | In distribution | |
| ST321002 | In distribution | |
| 32-10-11 | In distribution | |
| 32-13-12-I | In distribution | |
| ST321013 | In distribution | |
| ST321502IM | In distribution | |
| 32-22-601-I | In distribution | |
| 32-10-14A | In distribution | |
| 32-22-603-IV | In distribution | |
| 32-12-12-I | In distribution | |
| 32-20-403 | In distribution | |
| 32-12-13A | In distribution | |
| 32-10-02-EV | In distribution | |
| 32-10-04VI | In distribution | |
| 32-12-14-I | In distribution | |
| 32-10-11-EV | In distribution | |
| 32-12-14A | In distribution | |
| 32-12-13-EV | In distribution | |
| ST321211 | In distribution | |
| ST321113 | In distribution | |
| 32-12-11-I | In distribution | |
| 32-12-12 | In distribution | |
| ST322210 | In distribution | |
| ST322230V | In distribution | |
| 32-22-603-IM | In distribution | |
| ST321312I | In distribution | |
| ST321112 | In distribution | |
| ST321014IM | In distribution | |
| 32-10-02 | In distribution | |
| 32-10-12A | In distribution | |
| 32-11-13-IV | In distribution | |
| 32-12-11A | In distribution | |
| 32-19-02 | In distribution | |
| 32-10-01-IV | In distribution | |
| 32-20-404-IV | In distribution | |
| ST321011 | In distribution | |
| 32-12-00 | In distribution | |
| ST320915 | In distribution | |
| 32-10-04-I-F | In distribution | |
| ST321002IM | In distribution | |
| 32-16-12-I | In distribution | |
| ST304020 | In distribution | |
| 32-12-13-E | In distribution | |
| 32-20-404 | In distribution | |
| 32-10-12 | In distribution | |
| ST321011EV | In distribution | |
| 32-25-44-E | In distribution | |
| 51-250 | In distribution | |
| 32-22-30-V | In distribution | |
| ST321004IF | In distribution | |
| 32-12-02-I | In distribution | |
| 32-10-14-IV | In distribution | |
| 32-11-13 | In distribution | |
| 32-10-02-I | In distribution | |
| ST321213I | In distribution | |
| 32-11-13A | In distribution | |
| ST3220404 | In distribution | |
| 32-22-603-E | In distribution | |
| 32-12-02-IM | In distribution | |
| 91-5024 | In distribution | |
| 32-09-20 | In distribution | |
| 32-10-01-I | In distribution | |
| 32-10-13-I | In distribution | |
| ST3222601M | In distribution | |
| 32-10-11-IV | In distribution | |
| ST321213 | In distribution | |
| 32-12-12-I | In distribution | |
| 32-14-04 | In distribution | |
| 32-12-11 | In distribution | |
| 32-10-03-IM | In distribution | |
| 32-09-15 | In distribution | |
| 32-10-04 | In distribution | |
| 32-16-04-I | In distribution | |
| EL-GL11X | In distribution | |
| 32-19-400-IM | In distribution | |
| ST321014 | In distribution | |
| 32-16-12-E | In distribution | |
| ST321214I | In distribution | |
| 32-11-12 | In distribution | |
| 32-10-02-IV | In distribution | |
| ST321003IM | In distribution | |
| 32-10-12-E | In distribution | |
| 32-22-601-M | In distribution | |
| 32-12-14 | In distribution | |
| 32-10-05-IM | In distribution | |
| 33-10-01 | In distribution | |
| 30-40-20 | In distribution | |
| 32-10-02-IM | In distribution | |
| 32-10-13A-I | In distribution | |
| 32-14-12A | In distribution | |
| 32-16-02-I | In distribution | |
| 32-10-13 | In distribution | |
| 32-10-01-EV | In distribution | |
| ST321011A | In distribution | |
| 32-10-03-I | In distribution | |
| 32-12-13-I | In distribution | |
| 32-10-03E | In distribution | |
| ST321013A | In distribution | |
| EL-GL25 | In distribution | |
| ST321214 | In distribution | |
| 32-10-05-I-F | In distribution | |
| 32-13-11 | In distribution | |
| ST320920 | In distribution | |
| 32-10-14-IM | In distribution | |
| 32-10-13-IV | In distribution | |
| 32-10-12-IM | In distribution | |
| 32-12-15A | In distribution | |
| 32-10-01-IM | In distribution | |
| ST321212 | In distribution | |
| ST331001 | In distribution | |
| 32-22-652-I | In distribution | |
| ST321602I | In distribution | |
| 32-10-13A | In distribution | |
| 32-10-11A | In distribution | |
| 32-10-11-I | In distribution | |
| ST321200 | In distribution | |
| ST321404 | In distribution | |
| 71130-02IV | In distribution | |
| ST321012E | In distribution | |
| 32-10-14 | In distribution | |
| ST3220403 | In distribution | |
| 51-7078 | In distribution | |
| 32-20-403-IV | In distribution | |
| ST321005IF | In distribution | |
| ST321001IV | Withdrawn | |
| ST321011I | Withdrawn | |
| ST321002IV | Withdrawn | |
| ST321113IV | Withdrawn | |
| ST321012I | Withdrawn | |
| ST3222603EV | Withdrawn | |
| ST321013I | Withdrawn | |
| ST321004IV | Withdrawn | |
| ST321001EV | Withdrawn | |
| ST321013IV | Withdrawn | |
| 32-14-12A | Withdrawn | |
| ST321003EV | Withdrawn | |
| ST321612I | Withdrawn | |
| ST321604I | Withdrawn | |
| ST3222603E | Withdrawn | |
| ST321213E | Withdrawn | |
| ST321001E | Withdrawn | |
| ST321003IV | Withdrawn | |
| ST321211E | Withdrawn | |
| ST3222603IM | Withdrawn | |
| ST3222603IV | Withdrawn | |
| ST321202I | Withdrawn | |
| ST321014I | Withdrawn | |
| ST3219402IM | Withdrawn | |
| ST3219401IM | Withdrawn | |
| ST321001I | Withdrawn |
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 |
| 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 |
| 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.