Who else makes this device?

Name: ACE Single Lumen Ovum Pickup Needle
Brand: ACE Single Lumen Ovum Pickup Needle

ACE Single Lumen Ovum Pickup Needle · Needle, Assisted Reproduction → Obstetrics & Gynecology

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 ACE Single Lumen Ovum Pickup Needle
Listed by	Allwin Medical Devices, Inc., United States
FDA product code	MQE
Device type	Needle, Assisted Reproduction
Device class	Class 2
Regulation	21 CFR 884.6100
Establishment	Repacker / relabeller, Manufacturer, Exporter
510(k)	K190590
Record published	2020-04-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for ACE Single Lumen Ovum Pickup Needle
Catalogue number	Size	Status
A-OVM-SL17/35		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
K190590	2019-11-25

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.

ACE Single Lumen Ovum Pickup Needle