Integra® Jarit®
Integra® Jarit® Gills-Welsh Lens Loop, 4-3/4", Double-Ended, Olive Tip and 4.2mm x 6.3mm Loop
7manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Liaoning (2), Shanghai (1). 3 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 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Muling City Long SEN Wood Products Ltd. | Mudanjiang | Heilongjiang | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian | Liaoning | Contract manufacturer | 15 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HNB |
| Device type | Spoon, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-03 |
| Record revised | 2025-08-21 (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 |
| Sizes | Length 6.3 to 15 mm; width 4 to 5 mm |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350440 | In distribution | |
| 350441 | In distribution | |
| 350445 | In distribution | |
| 350430 | 4-3/4″ | In distribution |
| 350420 | 5-1/2″ | In distribution |
| 350415 | 5-1/2″ | In distribution |
| 350425 | 5-1/2″ | In distribution |
| X29591 | Withdrawn | |
| X29679 | Withdrawn | |
| X29597 | Withdrawn | |
| X29673 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Spoon | Katena Products, Inc. | 27 |
| Opthalmic Spoon | Ovation International | 21 |
| Sklar | Sklar Corporation | 11 |
| Spoon, Ophthalmic | Geuder Aktiengesellschaft | 10 |
| V. Mueller | Steris Corporation | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 9 |
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 7 |
| gSource | Gsource, LLC. | 7 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 7 |
| Bunge Evisceration Spoon | Sontec Instruments, Inc. | 6 |
| Hayden Medical | Hayden Medical Inc | 4 |
Showing 12 of 41. All products under Spoon, 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.