90×17 IVF Petridish Nontreated Vents
Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crystal-grade polystyrene. The dishes are used for preparing, storing, manipulating, or transferring…
Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crystal-grade polystyrene. The dishes are 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 dishes come in bags of 10 dishes, and each dish has a removable lid of the same virgin polystyrene as the dish itself. The dishes are irradiated in order to obtain sterility with a sterility assurance level of 10E-6. The dishes are designed in such a way that when the lid is mounted on the dish, the dishes can be stacked. The lid is easy to remove by one hand, which eases the use of the dish. The dishes have a flat, optically clear surface for optimum manipulation and observation of ovaries and embryos. The use of the dishes is specific to the procedure used in an IVF clinic. The dish 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 dishes. The product is tested for pyrogenicity, and mouse embryo toxicity assay tested. The dishes are shipped in bags of 10 in a box holding 150 dishes. The polystyrene used for the dish and the lid is virgin, crystal-grade polystyrene, which has passed the USP Class VI test for cytotox The use of the products depends on the validated protocols in the individual IVF clinics. Hence no Instruction for Use (IFU) is supplied with the products.
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 |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 150360 | 150 | 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 |
| Nunc IVF Multidish 4 Well Nunclon | Nunc A/S | 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 |
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.