PRO-Paks®️
Bulk Packaged Ultra Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA…
Bulk Packaged Ultra Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA PREMIUM Spears are 100% lint free. Bag of five pcs per foil 100 foils per bag.
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 | Microspecialities, Inc. |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Premarket notification | Exempt |
| Record published | 2018-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20, box of 15, box of 29 |
| Sizes | Outer diameter 6 to 8 mm; lumen/inner diameter 10 to 11.5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MK-108 | 10 | In distribution | |
| MK-600 | Lumen/Inner Diameter 11.5 mm | In distribution | |
| MK-110 | 10 | In distribution | |
| MK-500-6mm | Outer Diameter 6 mm | In distribution | |
| MK-501-8mm | Outer Diameter 8 mm | In distribution | |
| MK-302 | Lumen/Inner Diameter 10 mm | In distribution | |
| MK-500-8mm | Outer Diameter 8 mm | In distribution | |
| MK-103 | 10 | In distribution | |
| MK-502 | In distribution | ||
| MK-109 | 2 | In distribution | |
| MK-501-7mm | Outer Diameter 7 mm | In distribution | |
| MK-103B | 500 | In distribution | |
| MK-108B | 500 | In distribution | |
| MK-503 | In distribution | ||
| MK-301 | Lumen/Inner Diameter 11.5 mm | In distribution | |
| MK-100 | 10 | 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 |
| 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
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.