Integra® Miltex®
Integra® Miltex® Sims Vaginal Speculum 6-3/4", Large, Double-Ended, 1-1/8" x 3-3/8" and 1-1/2" x 4-1/8"
8manufacturers in China registered for this device type
47catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-18 |
| Record revised | 2023-04-27 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-15 | In distribution | |
| 30-188 | In distribution | |
| 30-25 | In distribution | |
| 30-90 | In distribution | |
| MH30-20 | In distribution | |
| 30-220 | In distribution | |
| 30-176 | In distribution | |
| MH30-15 | In distribution | |
| MH30-62 | In distribution | |
| V930-60 | In distribution | |
| 30-174 | In distribution | |
| MH30-30 | In distribution | |
| 30-195 | In distribution | |
| MH30-10 | In distribution | |
| V930-55 | In distribution | |
| V930-50 | In distribution | |
| V930-22 | In distribution | |
| 30-55 | In distribution | |
| 30-186 | In distribution | |
| 30-210 | In distribution | |
| 30-1350 | In distribution | |
| 30-62 | In distribution | |
| 30-193 | In distribution | |
| 30-140 | In distribution | |
| 30-30 | In distribution | |
| 30-215 | In distribution | |
| 30-141 | In distribution | |
| MH30-50 | In distribution | |
| MH30-60 | In distribution | |
| 30-63 | In distribution | |
| 30-187 | In distribution | |
| 30-100 | 1-3/8″ x 4″ | In distribution |
| 30-50 | 3-1/4″ x 1/2″ Blades | In distribution |
| 30-10 | In distribution | |
| V930-61 | In distribution | |
| V930-20 | In distribution | |
| V930-15 | In distribution | |
| 30-70 | In distribution | |
| 30-142 | In distribution | |
| MH30-55 | In distribution | |
| 30-1351 | In distribution | |
| V930-10 | In distribution | |
| 30-178 | In distribution | |
| 30-15A | In distribution | |
| 30-180 | In distribution | |
| 30-20 | In distribution | |
| 30-60 | 5″ x 1″ Blades | 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
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.