Nunc IVF Multidish 4 Well Nunclon
The Nunc IVF Multidish 4-Well Nunclon is a injection moulded polystyrene plate. The material is virgin, crystal-grade polystyrene. The plate is used for preparing, storing, manipulating, or…
The Nunc IVF Multidish 4-Well Nunclon is a injection moulded polystyrene plate. The material is virgin, crystal-grade polystyrene. The plate is used for preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques, and cell culture. The plate have 4 wells, and a number identifies each of the wells. The plate come in bags of 4 plates, and each plate has a removable lid of the same virgin polystyrene as the plate itself. The plates are irradiated in order to obtain sterility with a sterility assurance level of 10E-6. The interface between the plate and the lid is designed with one cut off corner. Hence the lid cannot be turned, and therefore cross-contamination is minimized. The plate is designed in such a way that when the lid is mounted on the plate, the plates can be stacked. The lid is easy to remove by one hand, which eases the use of the plate. The Nunc IVF 4-Well Dish has a flat, optically clear surface for optimum manipulation and observation of ovaries and embryos. The use of the plates is specific to the procedure used in an IVF clinic. The plate is manually handled, and the only critical thing that it needs to fit into is the heating block. Normally, the heating block is adapted for the plates. The Nunc IVF Multidish 4 Nunclon has a surface (Nunclon) treatment inside the wells, in order to obtain a cell culture suitable surface. The product is tested for pyrogenicity, and mouse embryo toxicity assay tested. The plates are shipped in bags of four in a box holding 120 plates. The polystyrene used for the plate and the lid is virgin, crystal-grade polystyrene, which has passed the USP Class VI test for cytotox
Who Else Makes It
Concentrated in Guangdong (5), Hubei (1), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Boomingshing Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
Record
| Listed by | Nunc A/S, Denmark |
|---|---|
| FDA product code | PUD |
| Device type | Labware, Assisted Reproduction, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-01 |
| Record revised | 2023-02-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 30 |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 144444 | 4 | In distribution | |
| 144444 | 120 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 12 |
| Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 10 |
| NovoSort | RSI Technology Group, LLC | 3 |
| SFG Sperm CD | Spectrum Fertility Group Inc. | 3 |
| Kitazato ReproPlate-K1(3Well) | Kitazato Corporation | 2 |
| Kitazato ReproPlate-K2 | Kitazato Corporation | 2 |
| Kitazato ReproPlate-K6 | Kitazato Corporation | 2 |
| Astec IVF 4Well Dish | Astec Co., Ltd. | 2 |
| Kitazato ReproPlate-K3 | Kitazato Corporation | 2 |
| SFG Sperm Collection Container | Spectrum Fertility Group Inc. | 1 |
| V-CULTUREDISH-60 | Vitromed GmbH | 1 |
| V-Sperm Morpho Slide | Vitromed GmbH | 1 |
Showing 12 of 52. All products under Labware, Assisted Reproduction, Exempt
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.