NUNC IVF MULTIDISH 4 WELL NUNCLON

Primary DI
05713311000014
Brand
NUNC IVF MULTIDISH 4 WELL NUNCLON
Company
Nunc A/S
Model
144444
Catalog number
144444
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
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2
PUDLabware, Assisted Reproduction, ExemptObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040717000NUNC IVF MULTIDISH 4 WELLS NUNCLONNunc A/S2004-08-12MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713311000014PrimaryGS10
15713311000011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713311000014057133110000145713311000014
1571331100001115713311000011

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4546312000info.nunc@thermofisher.com

Regulatory Flags#

DUNS number
305971764
Device count
120
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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