Surgical Direct
Vu-More Graves Vaginal Speculum, Medium, 100mm x 35mm, with Fixed Smoke Evacuation Tube, Insulated
8manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| 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 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | HDL |
| Device type | Retractor, Vaginal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-23 |
| Record revised | 2024-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD155225-0002 | In distribution | |
| SD155226-0002 | In distribution | |
| SD155221-0002 | In distribution | |
| SD165121 | In distribution | |
| SD155119 | In distribution | |
| SD155224 | In distribution | |
| SD155104 | In distribution | |
| SD155118 | In distribution | |
| SD165103 | In distribution | |
| SD155120 | In distribution | |
| SD155103 | In distribution | |
| SD155117DT | In distribution | |
| SD165111 | In distribution | |
| SD165102 | In distribution | |
| SD155102 | In distribution | |
| SD155203 | In distribution | |
| SD155202 | In distribution | |
| SD155221 | In distribution | |
| SD155118DT | In distribution | |
| SD155100 | In distribution | |
| SD165124 | In distribution | |
| SD165120 | In distribution | |
| SD165113 | In distribution | |
| SD165112 | In distribution | |
| SD155200 | In distribution | |
| SD1509910 | In distribution | |
| SD155225 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 72 |
| Ambler Surgical | Ambler Surgical, LLC | 60 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| HNM Medical | HNM Stainless, LLC. | 52 |
| Elmed Incorporated | Elmed, Inc. | 48 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 43 |
| Aesculap | Aesculap AG | 38 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 25 |
| Pilling | Teleflex Medical LLC | 25 |
| V. Mueller | Steris Corporation | 22 |
| Boss Instruments | Boss Instruments, Ltd. | 22 |
Showing 12 of 59. All products under Retractor, Vaginal
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.