Ambler Surgical
Lateral wall vaginal retractor, 9'', blades fit inside vaginal speculum, 2 1/2'' long insulated blades, closed shanks, ring handle with ratchet catch
8manufacturers in China registered for this device type
60catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-07 |
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 |
|---|---|---|
| Breisky vaginal retractor | In distribution | |
| Heaney-Simon hysterectomy retractor | In distribution | |
| Eastman vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Rigby self-retaining vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Kelly-Sims vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Heaney hysterectomy retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Lateral vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Kelly-Sims vaginal retractor | In distribution | |
| Jackson vaginal retractor | In distribution | |
| Doyen retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Kelly-Sims vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Jackson vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Heaney hysterectomy retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Lateral vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Lateral vaginal retractor | In distribution | |
| Eastman vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Heaney hysterectomy retractor | In distribution | |
| Jackson vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Doyen retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Jackson vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Eastman vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Sims vaginal retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Lateral wall vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Breisky vaginal retractor | In distribution | |
| Doyen retractor | In distribution | |
| Sims vaginal retractor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 72 |
| 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 |
| Surgical Direct | Surgical Direct, Inc. | 27 |
| 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.