Sponge, Ophthalmic
Eye Pledget, Lint free PVS eye sponges, 2mm x 6mm - 10 in one package
7manufacturers in China registered for this device type
12catalogue numbers in this listing
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 | Eagle Labs, LLC, United States |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-28 |
| Record revised | 2021-09-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20, carton of 10 |
| Sizes | Outer diameter 7 to 9 mm; lumen/inner diameter 9.5 to 12 mm; area/surface area 12 Square centimeter |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-08 | Outer Diameter 7 mm | In distribution |
| 600-10 | In distribution | |
| 600-30 | Lumen/Inner Diameter 9.5 mm | In distribution |
| 620-08 | Outer Diameter 8 mm | In distribution |
| 600-20 | Lumen/Inner Diameter 12 mm | In distribution |
| 620-10 | In distribution | |
| 620-09 | Outer Diameter 9 mm | In distribution |
| 600-40 | Lumen/Inner Diameter 11 mm | In distribution |
| 600-11 | In distribution | |
| 600-15 | In distribution | |
| 500-05 | Area/Surface Area 12 Square centimeter | In distribution |
| 500-01 | 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 |
| 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 |
| Coronet | Network Medical Products, Ltd. | 14 |
Showing 12 of 64. All products under Sponge, 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.