90×17 IVF Petridish Nontreated Vents

Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crystal-grade polystyrene. The dishes are used for preparing, storing, manipulating, or transferring…

Registry build 21.09.26

Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crystal-grade polystyrene. The dishes are 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 dishes come in bags of 10 dishes, and each dish has a removable lid of the same virgin polystyrene as the dish itself. The dishes are irradiated in order to obtain sterility with a sterility assurance level of 10E-6. The dishes are designed in such a way that when the lid is mounted on the dish, the dishes can be stacked. The lid is easy to remove by one hand, which eases the use of the dish. The dishes have a flat, optically clear surface for optimum manipulation and observation of ovaries and embryos. The use of the dishes is specific to the procedure used in an IVF clinic. The dish 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 dishes. The product is tested for pyrogenicity, and mouse embryo toxicity assay tested. The dishes are shipped in bags of 10 in a box holding 150 dishes. The polystyrene used for the dish and the lid is virgin, crystal-grade polystyrene, which has passed the USP Class VI test for cytotox The use of the products depends on the validated protocols in the individual IVF clinics. Hence no Instruction for Use (IFU) is supplied with the products.

7manufacturers in China registered for this device type
1catalogue number

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 90X17 IVF Petridish Nontreated Vents
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
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Distribution end date 2021-12-31

Catalogue Numbers

Catalogue numbers for 90X17 IVF Petridish Nontreated Vents
Catalogue number Size Per pack Status
150360 150 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
Nunc IVF Multidish 4 Well Nunclon Nunc A/S 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

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