Ophthalmic Spoon
Loop FOR Nucleus Divider Pack OF 3
7manufacturers in China registered for this device type
27catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNB |
| Device type | Spoon, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2023-10-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Width 2 to 5 mm; lumen/inner diameter 8.5 to 9.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K3-4160 | In distribution | |
| K3-1820 | Lumen/Inner Diameter 8.5 mm | In distribution |
| K3-1822 | Lumen/Inner Diameter 9.5 mm | In distribution |
| K3-4146 | In distribution | |
| K3-4120 | In distribution | |
| K3-5580 | In distribution | |
| K3-4152 | In distribution | |
| K3-4200 | In distribution | |
| K3-4450 | In distribution | |
| K3-4156 | Width 2 mm | In distribution |
| K3-4400 | In distribution | |
| K3-4030 | In distribution | |
| K3-4105 | In distribution | |
| K3-4145 | In distribution | |
| K3-4148 | In distribution | |
| K3-4010 | In distribution | |
| K3-3910 | In distribution | |
| K3-4141 | In distribution | |
| K3-3900 | In distribution | |
| K3-4157 | Width 3 mm | In distribution |
| K3-4150 | In distribution | |
| K3-4100 | In distribution | |
| K3-4263 | Width 5 mm | In distribution |
| K3-4140 | In distribution | |
| K3-4255 | In distribution | |
| K3-4410 | In distribution | |
| K3-4000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Opthalmic Spoon | Ovation International | 21 |
| Sklar | Sklar Corporation | 11 |
| Integra® Jarit® | Integra LifeSciences Production 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.