Coronet
Carton Label - Corneal Light Shield 10mm
7manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (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 |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Wenzhou Duola Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Wenzhou Easy & Lucky Optical Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | Network Medical Products, Ltd., United Kingdom |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K130117 |
| Record published | 2019-08-28 |
| Record revised | 2021-02-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-08-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 56-410 | 5 | In distribution | |
| 56-415 | 10 | In distribution | |
| 56-423 | 50 | In distribution | |
| 56-470 | 20 | In distribution | |
| 56-825 | 20 | In distribution | |
| 56-400 | 5 | In distribution | |
| 56-421 | 50 | In distribution | |
| 56-430 | 20 | In distribution | |
| 56-420 | 50 | In distribution | |
| 56-413 | 6 | In distribution | |
| 56-900 | 20 | In distribution | |
| 56-435 | 20 | In distribution | |
| 56-431 | 20 | In distribution | |
| 56-405 | 180 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eyetec | Network Medical Products, Ltd. | 71 |
| Ultracell | Beaver-Visitec International, Ltd | 44 |
| Merocel | Beaver-Visitec International, Ltd | 27 |
| Sugi | Questalpha GmbH & Co. KG | 22 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 18 |
| Netcell | Network Medical Products, Ltd. | 18 |
| DeRoyal | Deroyal Industries, Inc. | 17 |
| Eyetec | Summit Medical LLC | 17 |
| PRO-Paks®️ | Microspecialities, Inc. | 16 |
| Kitpack | Network Medical Products, Ltd. | 16 |
| Atlanta Healthcare Services OcuDrape® | Atlanta Healthcare Services | 14 |
| Sponge, Ophthalmic | Eagle Labs, LLC | 12 |
Showing 12 of 64. All products under Sponge, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130117 | 2013-10-29 |
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.