Atlanta Healthcare Services OcuDrape®
PVA Ophthalmic Wipe 3IN1 Wipe, Drain Wick, Corneal Light Shield 80mm x 76mm x 2mm STERILE
7manufacturers in China registered for this device type
14catalogue 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 | Atlanta Healthcare Services, United States |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K942642 |
| Record published | 2016-09-29 |
| Record revised | 2020-08-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Width 3 to 8 in; length 0.25 to 3 in; outer diameter 8 mm; height 1 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10852171007749 | Width 3.15 in | 400 | In distribution |
| 10852171007763 | Width 3.15 in | 400 | In distribution |
| 10852171007756 | Length 3 in | 40 | In distribution |
| 10852171007794 | Length 3 in | 40 | In distribution |
| 10852171007732 | Width 3 in | 40 | In distribution |
| 10852171007787 | Width 3.15 in | 400 | In distribution |
| 10852171007824 | Length 0.25 in | 400 | In distribution |
| 10852171007817 | Length 1.38 in | 40 | In distribution |
| 10852171007770 | Width 3.15 in | 40 | In distribution |
| 10852171007725 | Width 3 in | 400 | In distribution |
| 10852171007701 | Width 3.15 in | 400 | In distribution |
| 10852171007831 | Outer Diameter 8 mm | 400 | In distribution |
| 10852171007718 | Width 3.15 in | 40 | In distribution |
| 10852171007800 | Width 3 in | 400 | 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 |
| Coronet | Network Medical Products, Ltd. | 14 |
| Sponge, Ophthalmic | Eagle Labs, LLC | 12 |
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.