Mani Trocar Kit
3 catalogue numbers from MTK25S TROCAR KIT 25G S, listed by Mani, Inc., United States, under Cannula, Trocar, Ophthalmic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Mani, Inc., United States |
|---|---|
| FDA product code | NGY |
| Device type | Cannula, Trocar, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MTK25S TROCAR KIT 25G S | 3 | In distribution | |
| MTK23S TROCAR KIT 23G S | 3 | In distribution | |
| MTK27S TROCAR KIT 27G S | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alcon | Alcon Laboratories, Inc. | 10 |
| Cannula, Trocar, Ophthalmic | Microvision, Inc. | 7 |
| Mani Infusion Cannula | Mani, Inc. | 6 |
| Ophthalmic trocar | FCI S A S FCI 20 22 | 4 |
| Mani Trocar | Mani, Inc. | 3 |
| Unity | Alcon Laboratories, Inc. | 3 |
| Rumex | Rumex International Co. | 3 |
| Disposable one step single cannula including inserter. (25 gauge / 0.5 mm) | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 3 |
| 23G High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| 27G High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| Universal silicone infusion line for 20 gauge/0.9 mm cannula system. | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| 25G Cannula set with High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
Showing 12 of 52. All products under Cannula, Trocar, Ophthalmic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mani, Inc. (Head Office) | UDI-DI | 2023-02-20 | Class II | Process control | A packaging defect may compromise the sterile barrier. | 45 kits | 2025-05-19 |
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.