CustomEyes®
Kit Cataratta N°24 - Hospital Instruments S.R.L (SP/10)
67manufacturers in China registered for this device type
696catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (26), Shanghai (11), Zhejiang (9). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | Hubei | Contract manufacturer | 13 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Jiangsu Xuhe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 9 |
| Nanjing HI-Tech Tape Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 67. All 67 manufacturers in China registered for Kit, Surgical Instrument, Disposable
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | KDD |
| Device type | Kit, Surgical Instrument, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58001028 | In distribution | |
| 58000444 | In distribution | |
| 58001380 | In distribution | |
| 58001107 | In distribution | |
| 58000546 | In distribution | |
| 58000793 | In distribution | |
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| 58000293 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 789 |
| DeRoyal | Deroyal Industries, Inc. | 589 |
| Centurion | Centurion Medical Products Corporation | 277 |
| Readypak Kit | Beaver-Visitec International, Ltd | 196 |
| Custom Healthcare Systems, Inc. | Manus Medical, LLC | 78 |
| Medical Action Industries | Medical Action Industries, Inc. | 76 |
| Bioseal Inc. | Bioseal | 38 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 37 |
| In2Bones | IN2BONES USA, LLC | 24 |
| Aero-Med | Aero-MED LLC | 23 |
| Medline | Medline Industries, Inc. | 17 |
| McKesson | Mckesson Medical-Surgical Inc. | 17 |
Showing 12 of 252. All products under Kit, Surgical Instrument, Disposable
Recalls Naming This Product
158 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 | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 659 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 247 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 18 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Data in RES. | 4 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 49 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 100 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 19 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 40 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 73 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 230 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 122 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 35 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 103 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 84 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 198 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 58 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 351 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 69 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 117 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 84 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 149 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 43 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 214 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 124 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 388 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 40 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 154 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 217 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 45 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 162 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 23 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 80 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 211 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 105 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 76 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 54 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 2,117 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 68 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 237 units |
| Beaver-Visitec International, Ltd | UDI-DI | 2024-07-26 | Class II | No Marketing Application | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | 101 units |
Showing 40 of 158.
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.