BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NUNC IVF MULTIDISH 4 WELL NUNCLON

    DI: 05713311000014 · Model: 144444 · Nunc A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    120

    Basic Information

    Brand Name
    NUNC IVF MULTIDISH 4 WELL NUNCLON
    Primary DI
    05713311000014
    Version / Model
    144444
    Catalog Number
    144444
    Company Name
    Nunc A/S
    Labeler DUNS
    305971764
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    120
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    8
    Public Version Date
    2023-02-20
    Public Version Status
    Update
    Public Device Record Key
    6882d5e1-fba5-4449-be4e-17f7f2a5f1de
    Distribution End Date
    2021-12-31

    Device Description

    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

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUD Labware, Assisted Reproduction, Exempt

    GMDN Terms

    Code Name
    56648 Assisted reproduction procedure dish

    Identifiers

    Type ID
    Primary 05713311000014
    Unit of Use 15713311000011

    Customer Contacts

    Phone
    +4546312000
    Email
    [email protected]