DEVICE: NUNC IVF MULTIDISH 4 WELL NUNCLON (05713311000014)

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Device Identifier (DI) Information

NUNC IVF MULTIDISH 4 WELL NUNCLON
144444
144444
Nunc A/S
05713311000014
GS1
120
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Assisted reproduction procedure dish A sterile container intended 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. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and 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

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Product Code Product Code Name
MQK Labware, Assisted Reproduction
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 15713311000011 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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+4546312000
info.nunc@thermofisher.com
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