Novo Surgical Inc.
o'sullivan-o'connor self retaining vaginal speculum, complete set, consisting of frame (5259-05) w/ 2 lateral fixed blades, 3 removable center blades (5229-01, 5229-02, 5229-03)
8manufacturers in China registered for this device type
108catalogue 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 | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HDF |
| Device type | Speculum, Vaginal, Metal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OB6311-31 | In distribution | |
| OB6317-23ES | In distribution | |
| OB6338-98E | In distribution | |
| OB6312-15 | In distribution | |
| OB6322-33 | In distribution | |
| OB6330-11 | In distribution | |
| OB6355-37NCE | In distribution | |
| OB6318-01NC | In distribution | |
| OB6317-18ES | In distribution | |
| OB6340-66 | In distribution | |
| OB6338-05 | In distribution | |
| OB6330-60 | In distribution | |
| OB6330-69 | In distribution | |
| OB6338-98 | In distribution | |
| OB6316-23NC | In distribution | |
| OB6316-22 | In distribution | |
| OB6316-29 | In distribution | |
| OB6316-21 | In distribution | |
| OB6317-23E | In distribution | |
| OB6340-63 | In distribution | |
| OB6338-47 | In distribution | |
| OB6317-01 | In distribution | |
| OB6317-19 | In distribution | |
| OB6322-14 | In distribution | |
| OB6317-96 | In distribution | |
| OB6311-36NC | In distribution | |
| OB6311-66NC | In distribution | |
| OB6338-99 | In distribution | |
| OB6338-46 | In distribution | |
| OB6338-97 | In distribution | |
| OB6317-66 | In distribution | |
| OB6316-23 | In distribution | |
| OB6355-37NC | In distribution | |
| OB6317-23 | In distribution | |
| OB3153-12NC | In distribution | |
| OB6317-06 | In distribution | |
| OB6355-36NC | In distribution | |
| OB6316-21ES | In distribution | |
| OB6330-86 | In distribution | |
| OB6318-81NC | In distribution | |
| OB6335-22 | In distribution | |
| OB6317-09NC | In distribution | |
| OB6318-98 | In distribution | |
| OB6316-26 | In distribution | |
| OB6312-52 | In distribution | |
| OB6317-26NC | In distribution | |
| OB6340-66NC | In distribution | |
| OB6317-29 | In distribution | |
| OB6335-23 | In distribution | |
| OB6318-71ES | In distribution | |
| OB6317-18 | In distribution | |
| OB6355-36NCE | In distribution | |
| OB6317-21 | In distribution | |
| OB6338-04 | In distribution | |
| OB6317-21E | In distribution | |
| OB6318-66NC | In distribution | |
| OB6317-21ES | In distribution | |
| OB6311-46 | In distribution | |
| OB6318-01 | In distribution | |
| OB6318-03NC | In distribution | |
| OB6317-76 | In distribution | |
| OB6317-71NC | In distribution | |
| OB6330-71 | In distribution | |
| OB6317-18NC | In distribution | |
| OB6318-09NC | In distribution | |
| OB6318-93NC | In distribution | |
| OB6316-21C | In distribution | |
| OB6311-36 | In distribution | |
| OB6330-66 | In distribution | |
| OB6318-71E | In distribution | |
| OB6317-23NC | In distribution | |
| OB6318-81 | In distribution | |
| OB6330-72 | In distribution | |
| OB6417-21NC | In distribution | |
| OB6317-81NC | In distribution | |
| OB6317-01NC | In distribution | |
| OB6318-76 | In distribution | |
| OB6316-23ES | In distribution | |
| OB6316-21NC | In distribution | |
| OB6318-98NC | In distribution | |
| OB6317-71 | In distribution | |
| OB6318-71 | In distribution | |
| OB6311-46NC | In distribution | |
| OB6318-61 | In distribution | |
| OB6317-18E | In distribution | |
| OB6311-41 | In distribution | |
| OB6317-26 | In distribution | |
| OB6340-61 | In distribution | |
| OB6317-09 | In distribution | |
| OB6340-62NC | In distribution | |
| OB6311-41NC | In distribution | |
| OB6318-96 | In distribution | |
| OB6340-62 | In distribution | |
| OB6317-29NC | In distribution | |
| OB6318-96NC | In distribution | |
| OB6317-26ES | In distribution | |
| OB6318-76NC | In distribution | |
| OB6340-63NC | In distribution | |
| OB6316-18 | In distribution | |
| OB6311-56NC | In distribution | |
| OB6318-06 | In distribution | |
| OB6317-21NC | In distribution | |
| OB6318-66 | In distribution | |
| OB6338-48 | In distribution | |
| OB6318-71NC | In distribution | |
| OB6318-09 | In distribution | |
| OB6316-18NC | In distribution | |
| OB6317-81 | 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 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 105 |
| Aesculap | Aesculap AG | 102 |
| BR Surgical, LLC | BR Surgical LLC | 94 |
| Ambler Surgical | Ambler Surgical, LLC | 92 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 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.