What is FDA product code PUD?

This product code is the class II exempt counterpart of MQK, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › MiscellaneousLabware, Assisted Reproduction, Exempt

Nunc IVF Dish 35mmNON-TREATED

Name: Nunc IVF Dish 35mmNON-TREATED
Brand: Nunc IVF Dish 35mmNON-TREATED

Catalogue number 150255, listed by Nunc A/S, Denmark, under Labware, Assisted Reproduction, Exempt. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26

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 Nunc IVF Dish 35mmNON-TREATED
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	2018-09-21
Record revised	2023-02-20 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Radiation Sterilization
Supplied sterile	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Case of 50

Catalogue Numbers

Catalogue numbers for Nunc IVF Dish 35mmNON-TREATED
Catalogue number	Size	Per pack	Status
150255		10	In distribution

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.