Integra® Jarit®
Integra® Jarit® Maumenee-Park Eye Speculum, Fenestrated, With Canthus Bar, 14.5mm Blades, 43mm Spread
11manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-10-31 |
| Record revised | 2023-04-20 (version 7) |
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 |
| Sizes | Width 2.5 to 18 mm; length 14 mm; length 1 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 350092 | In distribution | ||
| 350100 | In distribution | ||
| X2945 | 2-1/2″ | In distribution | |
| 350121 | In distribution | ||
| X2977 | In distribution | ||
| 350130 | In distribution | ||
| 350093 | Length 14 mm | In distribution | |
| 350112 | In distribution | ||
| X2961 | In distribution | ||
| 350118 | In distribution | ||
| 350120 | In distribution | ||
| 350125 | In distribution | ||
| 350095 | In distribution | ||
| 350090 | In distribution | ||
| 350094 | 9mm x 4.5mm Blades, 12mm Spread | In distribution | |
| 350110 | In distribution | ||
| X2940 | 2-3/8″ | In distribution | |
| X2979 | In distribution | ||
| X294 | Width 2.5 mm | In distribution | |
| 350101 | In distribution | ||
| X295 | In distribution | ||
| X2975 | In distribution | ||
| 350119 | In distribution | ||
| 350126 | In distribution | ||
| 350097 | In distribution | ||
| 350105 | In distribution | ||
| 350098 | In distribution | ||
| 350096 | In distribution | ||
| 350TSC112 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 214 |
| Ambler Surgical | Ambler Surgical, LLC | 169 |
| Sklar | Sklar Corporation | 121 |
| Walcott Rx Products | Walcott Rx Product Inc | 115 |
| Ophthalmic Speculum | Aurora Surgical, LLC | 93 |
| MR Phaco | Crestpoint Management Ltd. | 84 |
| Millennium | Avalign Technologies, Inc. | 79 |
| Ophthalmic Speculum | Katena Products, Inc. | 76 |
| Stephens Instruments | Krishna Imports Inc | 61 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 55 |
| Surtex | Surtex Instruments Ltd | 54 |
| Rumex | Rumex International Co. | 47 |
Showing 12 of 360. All products under Specula, Ophthalmic
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.