RZ Medizintechnik GmbH
O'Sullivan-O'Connor vaginal Retractor complete,incl. 2 Valve 350-336-003 1 frame 350-336-020,1 valve 350-336-004
8manufacturers in China registered for this device type
92catalogue 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 | RZ Medizintechnik Gmbh, Germany |
|---|---|
| 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 | 2024-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350-120-001 | In distribution | |
| 350-290-005 | In distribution | |
| 350-309-000 | In distribution | |
| 350-100-002 | In distribution | |
| 350-365-010 | In distribution | |
| 350-200-001 | In distribution | |
| 350-140-003 | In distribution | |
| 350-102-001 | In distribution | |
| 350-100-001 | In distribution | |
| 350-210-003 | In distribution | |
| 350-140-002 | In distribution | |
| 350-290-010 | In distribution | |
| 350-230-001 | In distribution | |
| 350-130-002 | In distribution | |
| 310-116-140 | In distribution | |
| 350-207-002 | In distribution | |
| 350-322-040 | In distribution | |
| 350-102-003 | In distribution | |
| 100-113-240 | In distribution | |
| 350-231-003 | In distribution | |
| 350-230-002 | In distribution | |
| 350-361-001 | In distribution | |
| 350-290-011 | In distribution | |
| 350-320-020 | In distribution | |
| 350-290-008 | In distribution | |
| 350-322-035 | In distribution | |
| 350-200-002 | In distribution | |
| 350-290-002 | In distribution | |
| 350-130-001 | In distribution | |
| 350-102-002 | In distribution | |
| 350-232-001 | In distribution | |
| 100-111-200 | In distribution | |
| 330-301-005 | In distribution | |
| 350-322-030 | In distribution | |
| 350-212-001 | In distribution | |
| 350-207-003 | In distribution | |
| 350-211-003 | In distribution | |
| 350-207-001 | In distribution | |
| 350-210-000 | In distribution | |
| 330-301-003 | In distribution | |
| 350-150-002 | In distribution | |
| 350-110-002 | In distribution | |
| 350-110-003 | In distribution | |
| 350-365-012 | In distribution | |
| 350-340-000 | In distribution | |
| 350-361-002 | In distribution | |
| 350-140-001 | In distribution | |
| 330-301-001 | In distribution | |
| 350-212-003 | In distribution | |
| 350-232-003 | In distribution | |
| 350-320-030 | In distribution | |
| 350-230-003 | In distribution | |
| 350-290-006 | In distribution | |
| 350-336-004 | In distribution | |
| 350-322-020 | In distribution | |
| 350-206-003 | In distribution | |
| 350-320-035 | In distribution | |
| 350-200-003 | In distribution | |
| 350-322-025 | In distribution | |
| 350-365-014 | In distribution | |
| 350-120-002 | In distribution | |
| 350-211-001 | In distribution | |
| 350-110-001 | In distribution | |
| 350-100-003 | In distribution | |
| 350-210-001 | In distribution | |
| 330-301-004 | In distribution | |
| 350-231-001 | In distribution | |
| 350-336-000 | In distribution | |
| 350-206-001 | In distribution | |
| 350-310-000 | In distribution | |
| 350-311-000 | In distribution | |
| 350-320-025 | In distribution | |
| 350-212-002 | In distribution | |
| 350-206-002 | In distribution | |
| 350-110-004 | In distribution | |
| 350-324-040 | In distribution | |
| 350-211-000 | In distribution | |
| 350-232-002 | In distribution | |
| 330-301-002 | In distribution | |
| 350-290-004 | In distribution | |
| 350-290-007 | In distribution | |
| 350-290-001 | In distribution | |
| 350-320-040 | In distribution | |
| 350-211-002 | In distribution | |
| 350-361-003 | In distribution | |
| 350-311-140 | In distribution | |
| 350-130-003 | In distribution | |
| 350-290-009 | In distribution | |
| 350-290-003 | In distribution | |
| 350-212-000 | In distribution | |
| 350-210-002 | In distribution | |
| 350-231-002 | 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 |
| Gynex | Gynex Corporation | 91 |
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.