Who else makes this device?

Name: Kitazato OPU Two-Stage Reduced Needle, Type4-v1
Brand: Kitazato OPU Two-Stage Reduced Needle, Type4-v1

Obstetrics & Gynecology › MiscellaneousNeedle, Assisted Reproduction

Kitazato OPU Two-Stage Reduced Needle, Type4-V1

Catalogue number 381302 Type4-v1, listed by Kitazato Corporation, Japan, under Needle, Assisted Reproduction. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code MQE
Manufacturer	City	Province	Registered as	Device types
Dongguan King Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Shenzhen VitaVitro Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7
Gimbo Medical Technology Shenzhen Co., Ltd.	Shenzhen	Guangdong	Manufacturer	3

Record

Regulatory record for Kitazato OPU Two-Stage Reduced Needle, Type4-v1
Listed by	Kitazato Corporation, Japan
FDA product code	MQE
Device type	Needle, Assisted Reproduction
Device class	Class 2
Regulation	21 CFR 884.6100
Establishment	Complaint-file establishment, Manufacturer, Exporter
510(k)	K162881
Record published	2018-05-30
Record revised	2023-08-07 (version 6)

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, serial number
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Kitazato OPU Two-Stage Reduced Needle, Type4-v1
Catalogue number	Size	Status
381302 Type4-v1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cook	William A. Cook Australia PTY, Ltd.	71
Follicle Aspiration Set Single Lumen	Vitrolife Sweden AB	40
Follicle Aspiration Set, Double Lumen	Vitrolife Sweden AB	28
Wallace	ICU Medical, Inc	20
Kitazato OPU Needle with Connection Tube, Type2-v17	Kitazato Corporation	18
Labotect	Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung	16
Kitazato OPU Needle	Kitazato Corporation	12
Follicle Aspiration Set Reduced Single Lumen	Vitrolife Sweden AB	11
Follicle Aspiration Set Single Lumen, Luer	Vitrolife Sweden AB	9
Needle Guide	Civco Medical Instruments Co., Inc.	8
17G Wallace Dual Lumen Oocyte Recovery Set	Coopersurgical, Inc.	3
ACE-M	Allwin Medical Devices, Inc.	3

Showing 12 of 65. All products under Needle, Assisted Reproduction

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K162881	2017-07-11
K112462	2012-11-26

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.