Duns Number:305971764
Device Description: Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crys 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 cytotoxThe 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.
Catalog Number
150360
Brand Name
90X17 IVF PETRIDISH NONTREATED VENTS
Version/Model Number
150360
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUD
Product Code Name
Labware, Assisted Reproduction, Exempt
Public Device Record Key
c9fe1c2e-6a29-4f42-b18f-aefabf5667ee
Public Version Date
December 31, 2021
Public Version Number
7
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |