Breast Aspiration Dual-Port Biopsy Needle

Dual-port needle with 3-finger control 12cc syringe, 1.5"

Registry build 21.09.26
5manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Tianjin (1), Guangdong (1).

Chinese manufacturers registered for FDA product code MJG
Manufacturer City Province Registered as Device types
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Tianjin Newtrans Technology Development Tianjin Tianjin Exporter 11
Carbon (Shenzhen) Medical Device Co., Ltd. Shenzhen Guangdong Manufacturer 6
Ningbo Hicren Biotechnology Co., Ltd. Ningbo Zhejiang Manufacturer 5
Canyon Medical Inc. Nanjing Jiangsu Manufacturer 4

Record

Regulatory record for Breast Aspiration Dual-Port Biopsy Needle
Listed by Coopersurgical, Inc., United States
FDA product code MJG
Device type Device, Percutaneous, Biopsy
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-08-14
Record revised 2024-02-28 (version 4)

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
Packaging Pack of 5, pack of 12

Catalogue Numbers

Catalogue numbers for Breast Aspiration Dual-Port Biopsy Needle
Catalogue number Size Status
MX42 In distribution
MX41 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 392
Cook Cook Incorporated 77
Intro M.D.L. S.R.L. 34
Franseen Cook Incorporated 32
HandCut M.D.L. S.R.L. 22
Turner Cook Incorporated 15
Palium Needle M.D.L. S.R.L. 14
Primocut Pajunk Gmbh Medizintechnologie 13
FastCutP M.D.L. S.R.L. 10
Co-Axial Cannula Bundle Argon Medical Devices, Inc. 10
Medline Industries, Inc. Medline Industries, Inc. 10
Greene Cook Incorporated 10

Showing 12 of 44. All products under Device, Percutaneous, Biopsy

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