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NUNCA DEMORA FITNESS INC

Matched from indexed company URL: NUNC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30159377113015937711NUNCA DEMORA FITNESS INC1Y2020-04-25228 Park Ave S #79525 New York NY US 10003

PMN#

GUDID#

90X17 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 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.

Nunc A/S

2016-09-01

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 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

Nunc A/S

2016-09-01

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