DEVICE: NUNC IVF MULTIDISH 4 WELL NUNCLON (05713311000014)
Device Identifier (DI) Information
NUNC IVF MULTIDISH 4 WELL NUNCLON
144444
Not in Commercial Distribution
144444
Nunc A/S
144444
Not in Commercial Distribution
144444
Nunc A/S
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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56648 | Assisted reproduction procedure dish |
A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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PUD | Labware, Assisted Reproduction, Exempt |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6882d5e1-fba5-4449-be4e-17f7f2a5f1de
February 20, 2023
8
September 01, 2016
February 20, 2023
8
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
15713311000011
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4546312000
info.nunc@thermofisher.com
info.nunc@thermofisher.com