Ultracell
'instrument Wipe, Foil Pouched 3'' X 3'' X 2MM (300/SP)'
7manufacturers in China registered for this device type
44catalogue numbers in this listing
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 | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2026-05-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40400-8 | 1,250 | In distribution | |
| 40430 | 20 | In distribution | |
| S90900 | In distribution | ||
| 40451 | 10 | In distribution | |
| NS40431Z | In distribution | ||
| BS40400 | 5,000 | In distribution | |
| NS40810 | 2,500 | In distribution | |
| 47306 | 2,500 | In distribution | |
| 40431 | 20 | In distribution | |
| BNS40410 | 5,000 | In distribution | |
| NS40430 | 500 | In distribution | |
| 40462 | In distribution | ||
| 40415 | 200 | In distribution | |
| BS40400-8 | 5,000 | In distribution | |
| 40804 | 40 | In distribution | |
| NS40300FF | 2,500 | In distribution | |
| NS40300 | 2,500 | In distribution | |
| 40800 | 40 | In distribution | |
| 40805 | 100 | In distribution | |
| 90950 | In distribution | ||
| NS40415 | 1,000 | In distribution | |
| NS40413 | 600 | In distribution | |
| NS40200 | 2,500 | In distribution | |
| 49001 | 500 | In distribution | |
| S40462-COP | In distribution | ||
| 40810 | 100 | In distribution | |
| NS40400-8 | 2,500 | In distribution | |
| NS40800 | 200 | In distribution | |
| BNS40415 | 10,000 | In distribution | |
| NS40462 | In distribution | ||
| NS40410Z | 5,000 | In distribution | |
| 40405-8 | 200 | In distribution | |
| 40412 | 20 | In distribution | |
| 40825 | 200 | In distribution | |
| 90900 | In distribution | ||
| 40410 | 100 | In distribution | |
| 8302440 | 20,000 | In distribution | |
| BNS40413 | 6,000 | In distribution | |
| NS40410 | 500 | In distribution | |
| NS40811 | 2,500 | In distribution | |
| S40400-8 | 2,500 | In distribution | |
| NS40450 | 300 | In distribution | |
| 40413 | 144 | In distribution | |
| NS40470Z | 300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eyetec | Network Medical Products, Ltd. | 71 |
| 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 |
| Sponge, Ophthalmic | Eagle Labs, LLC | 12 |
Showing 12 of 64. All products under Sponge, Ophthalmic
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Beaver-Visitec International, Ltd | UDI-DI | 2022-12-20 | Class II | Process control | Device packaging may contain open seals, compromising product sterility. | 4640 units in total |
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 2 Box |
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.