Aesculap
TUEBINGEN Vaginal Retractor, 10 1/2", (265 mm), depth: 95 mm, width: 20 mm, non-sterile, reusable
8manufacturers in China registered for this device type
38catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | HDL |
| Device type | Retractor, Vaginal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-20 |
| Record revised | 2021-07-29 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BV997R | In distribution | |
| EL632R | In distribution | |
| EL636R | In distribution | |
| MB068R | In distribution | |
| EL639R | In distribution | |
| EL870R | In distribution | |
| MB760R | In distribution | |
| MB489 | In distribution | |
| MB765R | In distribution | |
| EL498R | In distribution | |
| EL873R | In distribution | |
| EL872R | In distribution | |
| EL635R | In distribution | |
| EL581R | In distribution | |
| MB493 | In distribution | |
| BV087R | In distribution | |
| EL638R | In distribution | |
| MB764R | In distribution | |
| MB759R | In distribution | |
| MB490 | In distribution | |
| MB492 | In distribution | |
| EL633R | In distribution | |
| MB761R | In distribution | |
| MG177R | In distribution | |
| MG170R | In distribution | |
| EL642R | In distribution | |
| MD411 | In distribution | |
| MD410 | In distribution | |
| EL631R | In distribution | |
| EL497R | In distribution | |
| EL644R | In distribution | |
| MG176R | In distribution | |
| EL868R | In distribution | |
| BV996R | In distribution | |
| MG492R | In distribution | |
| EL634R | In distribution | |
| MB491 | In distribution | |
| EL637R | 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 |
| 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.