What is FDA product code PUC?

This product code is the class II exempt counterpart of MQH, 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 › MiscellaneousMicrotools, Assisted Reproduction (Pipettes), Exempt

V-Icsipet Polar Body Biopsy

Name: V-Icsipet Polar Body Biopsy
Brand: V-Icsipet Polar Body Biopsy

V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET POLAR BODY BIOPSY…

Registry build 21.09.26

V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET POLAR BODY BIOPSY pipettes are for the removal of the polar bodies of mature oocytes and oocytes in the pronuclear stage.

8manufacturers in China registered for this device type

4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PUC
Manufacturer	City	Province	Registered as	Device types
Jiangsu Kangjian Medical Apparatus Co., Ltd.	Jiangyan	Jiangsu	Contract manufacturer	19
Guangzhou Huada Biotechnology Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	9
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
UKS Medical Technology (Chongqing) Co., Ltd.	Chongging	Sichuan	Contract manufacturer	4
Arsci Biomedical Inc.	Jiaxing	Zhejiang	Manufacturer	2
Donnevie Medical Technology (Shanghai) Co., Ltd.	Shanghai	Shanghai	Manufacturer	1

Record

Regulatory record for V-Icsipet Polar Body Biopsy
Listed by	Vitromed GmbH, Germany
FDA product code	PUC
Device type	Microtools, Assisted Reproduction (Pipettes), Exempt
Device class	Class 2
Regulation	21 CFR 884.6130
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-03-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for V-Icsipet Polar Body Biopsy
Catalogue number	Per pack	Status
V-ICSIPET Polar Body Biopsy 20	10	In distribution
V-ICSIPET Polar Body Biopsy 25	10	In distribution
V-ICSIPET Polar Body Biopsy 35	10	In distribution
V-ICSIPET Polar Body Biopsy 30	10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sunbiotec	Hubei Huamei Sunlight Biotechnologies Co., Ltd.	435
SLM	Sunlight Medical, Inc.	303
TPC	Coopersurgical, Inc.	91
Icsi Pipette	Vitrolife Sweden AB	63
Astec	Astec BIO USA Inc	52
Biopsy Pipette	Vitrolife Sweden AB	34
Kitazato Injection Micropipette	Kitazato Corporation	25
Holding Pipette	Vitrolife Sweden AB	23
Dewin	Donnevie Medical Technology (Shanghai) Co., Ltd.	21
Brilliant Biopsy Micropipette	Hamilton Thorne, Inc.	14
Intelligent Icsi Micropipette	Hamilton Thorne, Inc.	13
SFG Denuding pipettes	Spectrum Fertility Group Inc.	12

Showing 12 of 38. All products under Microtools, Assisted Reproduction (Pipettes), 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.