Integra® Jarit®
Integra® Jarit® Fansler Operating Speculum, 7-3/4", Slotted Tube, 1-3/8" Wide x 2-3/8" Deep
8manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Jiangsu (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 |
| 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 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FFQ |
| Device type | Speculum, Rectal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-09 |
| Record revised | 2025-03-12 (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 |
| Sizes | Outer diameter 22 to 32 mm; width 18 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 475OBT142 | In distribution | |
| 475127 | In distribution | |
| 475110 | In distribution | |
| 475165 | Width 18 mm | In distribution |
| 475105 | In distribution | |
| 475187 | In distribution | |
| 475186 | In distribution | |
| 475185 | In distribution | |
| X3921 | In distribution | |
| 475142 | In distribution | |
| X3922 | In distribution | |
| X3963 | In distribution | |
| X3947 | 1-1/2″ | In distribution |
| X3949 | Outer Diameter 27.2 mm | In distribution |
| 475OBT127 | In distribution | |
| 475176 | In distribution | |
| 475180 | In distribution | |
| 475OBT152 | In distribution | |
| 475100 | In distribution | |
| 475152 | In distribution | |
| 475177 | In distribution | |
| 475150 | In distribution | |
| 475140 | In distribution | |
| 475OBT155 | In distribution | |
| 475189 | In distribution | |
| 475162 | In distribution | |
| 475175 | In distribution | |
| 475125 | In distribution | |
| 475181 | In distribution | |
| 475160 | In distribution | |
| 475130 | In distribution | |
| 475131 | In distribution | |
| 475182 | In distribution | |
| 475155 | In distribution | |
| 475120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surtex | Surtex Instruments Ltd | 87 |
| Millennium | Avalign Technologies, Inc. | 37 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 36 |
| Elmed | Elmed, Inc. | 36 |
| Hayden Medical | Hayden Medical Inc | 30 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 25 |
| HNM Medical | HNM Stainless, LLC. | 25 |
| Aesculap | Aesculap AG | 25 |
| Sklar® | Sklar Corporation | 17 |
| Pilling | Teleflex Medical LLC | 17 |
| Novo Surgical | Novo Surgical, Inc. | 15 |
| Elmed Incorporated | Elmed, Inc. | 15 |
Showing 12 of 65. All products under Speculum, Rectal
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.