Lateral Retractor
Lateral Retractor with offset blades
8manufacturers in China registered for this device type
1catalogue number
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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | HDL |
| Device type | Retractor, Vaginal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-06 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9086186 | 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 |
| Surgical Direct | Surgical Direct, Inc. | 27 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 25 |
| Pilling | Teleflex Medical LLC | 25 |
| V. Mueller | Steris Corporation | 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.