Integra® Jarit®
Integra® Jarit® Miltex-Kogan Endocervical Speculum, 10-3/4", With Gauge and Ratchet, Jaws 3mm x 23mm
8manufacturers in China registered for this device type
51catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| 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 | 2017-05-16 |
| Record revised | 2023-04-24 (version 6) |
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 |
| Storage | Special storage condition: No |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X4174 | In distribution | |
| 500138 | In distribution | |
| 500142 | In distribution | |
| 500503 | In distribution | |
| 500105 | In distribution | |
| 500182 | In distribution | |
| X41251 | In distribution | |
| 500173 | In distribution | |
| 500110 | In distribution | |
| 500147 | In distribution | |
| X41253 | In distribution | |
| 500507 | In distribution | |
| X41291 | In distribution | |
| 500180 | In distribution | |
| 500145 | In distribution | |
| 500143 | In distribution | |
| X4181 | In distribution | |
| 500175 | In distribution | |
| 500509 | In distribution | |
| 500125 | 6″ | In distribution |
| 500139 | In distribution | |
| 500172 | In distribution | |
| 500115 | 4-3/8″ | In distribution |
| X4136 | In distribution | |
| 500130 | In distribution | |
| 500186 | In distribution | |
| 500185 | In distribution | |
| 500146 | In distribution | |
| 500174 | In distribution | |
| 500265 | 9-3/4″ | In distribution |
| 500510 | In distribution | |
| X41299 | In distribution | |
| 500504 | In distribution | |
| 500505 | In distribution | |
| 500506 | In distribution | |
| 500501 | In distribution | |
| 500135 | In distribution | |
| 500141 | In distribution | |
| X41297 | In distribution | |
| X412462 | In distribution | |
| 500502 | In distribution | |
| 500148 | In distribution | |
| X41252 | In distribution | |
| 500184 | In distribution | |
| 500508 | In distribution | |
| 500181 | In distribution | |
| 500137 | In distribution | |
| 500120 | 5-1/4″ | In distribution |
| X4126B | In distribution | |
| 500100 | In distribution | |
| 500170 | 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 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 92 |
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.