DeRoyal
Eye Spear / Fine Dissector
7manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
1recall
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2021-08-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10, box of 20, box of 25, case of 50, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-049 | In distribution | |
| 30-049-P5 | In distribution | |
| 17-052 | In distribution | |
| 34-507 | In distribution | |
| QM-16355 | In distribution | |
| 34-503 | In distribution | |
| 34-504 | In distribution | |
| 30-049-10 | In distribution | |
| 30-049NS | In distribution | |
| 34-502 | In distribution | |
| 34-507NS | In distribution | |
| 34-506 | In distribution | |
| 30-049-6 | In distribution | |
| 25-201 | In distribution | |
| 30-049NS-T | In distribution | |
| 34-504NS | In distribution | |
| 25-201NS | In distribution |
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 |
| Eyetec | Summit Medical LLC | 17 |
| PRO-Paks®️ | Microspecialities, Inc. | 16 |
| Kitpack | Network Medical Products, Ltd. | 16 |
| Atlanta Healthcare Services OcuDrape® | Atlanta Healthcare Services | 14 |
| Coronet | Network Medical Products, Ltd. | 14 |
| Sponge, Ophthalmic | Eagle Labs, LLC | 12 |
Showing 12 of 64. All products under Sponge, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972693 | 1997-09-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-08-12 | Class II | Employee error | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. | 726 cases (7242 units) | 2014-08-04 |
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.