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…

Registry build 21.09.26

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

7manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Hubei (1), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PUD
Manufacturer City Province Registered as Device types
Shenzhen Boomingshing Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Wuhan Huchuang Union Technology Co., Ltd. Wuhan Hubei Manufacturer 8
Shenzhen VitaVitro Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 7
Guangzhou Pinzhi Medical Device Co., Ltd. Guangzhou Guangdong Manufacturer 5
CGN Gray (Shenzhen) Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
UKS Medical Technology (Chongqing) Co., Ltd. Chongging Sichuan Contract manufacturer 4

Record

Regulatory record for Nunc IVF Multidish 4 Well Nunclon
Listed by Nunc A/S, Denmark
FDA product code PUD
Device type Labware, Assisted Reproduction, Exempt
Device class Class 2
Regulation 21 CFR 884.6160
Establishment Manufacturer
Premarket notification Exempt
Record published 2016-09-01
Record revised 2023-02-20 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Case of 30
Distribution end date 2021-12-31

Catalogue Numbers

Catalogue numbers for Nunc IVF Multidish 4 Well Nunclon
Catalogue number Size Per pack Status
144444 4 In distribution
144444 120 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
VitaVitro Shenzhen VitaVitro Biotech Co., Ltd. 12
Metiec Wuhan Huchuang Union Technology Co., Ltd. 10
NovoSort RSI Technology Group, LLC 3
SFG Sperm CD Spectrum Fertility Group Inc. 3
Kitazato ReproPlate-K1(3Well) Kitazato Corporation 2
Kitazato ReproPlate-K2 Kitazato Corporation 2
Kitazato ReproPlate-K6 Kitazato Corporation 2
Astec IVF 4Well Dish Astec Co., Ltd. 2
Kitazato ReproPlate-K3 Kitazato Corporation 2
SFG Sperm Collection Container Spectrum Fertility Group Inc. 1
V-CULTUREDISH-60 Vitromed GmbH 1
V-Sperm Morpho Slide Vitromed GmbH 1

Showing 12 of 52. All products under Labware, Assisted Reproduction, Exempt

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer