Breast Localization Needles

Accura™ II BLN with Stiffening Cannula 20ga x 12.5cm

Registry build 21.09.26
37manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (7), Shanghai (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAA
Manufacturer City Province Registered as Device types
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Shanghai Kindly Enterprise Development Group Co., Ltd. Jiading Shanghai Contract manufacturer 11
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Taihu Anhui Contract manufacturer 8
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Ningbo Tianbo First AID Product Co., Ltd. Ningbo Zhejiang Repacker / relabeller 66
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Dongguan City Ruimi Gift Products Co Ltd Dongguan Guangdong Repacker / relabeller 62
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43

Showing 12 of 37. All 37 manufacturers in China registered for Needle, Aspiration And Injection, Disposable

Record

Regulatory record for Breast Localization Needles
Listed by Argon Medical Devices, Inc., United States
FDA product code GAA
Device type Needle, Aspiration And Injection, Disposable
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-07-05
Record revised 2026-05-11 (version 5)

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, manufacturing date
Storage Special storage condition: Keep dry and away from sunlight
Packaging Box of 10
Distribution end date 2024-12-06

Catalogue Numbers

Catalogue numbers for Breast Localization Needles
Catalogue number Size Status
231050G 20ga x 5cm In distribution
BLN20075 20ga x 7.5cm In distribution
266050 20ga x 5cm In distribution
231075G 20ga x 7.5cm In distribution
BLN21075 21ga x 7.5cm In distribution
BLN2010 20ga x 10cm In distribution
266075 20ga x 7.5cm In distribution
BLN2110 21ga x 10cm In distribution
BLN2005 20ga x 5cm In distribution
231125G 20ga x 12.5cm In distribution
231030G 20ga x 3cm In distribution
BLN2015 20ga x 15cm In distribution
BLN2105 21ga x 5cm In distribution
BLN2003 20ga x 3cm In distribution
231100G 20ga x 10cm In distribution
266100 20ga x 10cm In distribution
BLND20075 20ga x 7.5cm Withdrawn
BLN2103 21ga x 3cm Withdrawn
BLND2010 20ga x 10cm Withdrawn
BLND2003 20ga x 3cm Withdrawn
BLND2005 20ga x 5cm Withdrawn
BLND2015 20ga x 15cm Withdrawn
266125 20ga x 12.5cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 298
Anodyne Surgical Psi/Eye-Ko, Inc. 148
Zavation Zavation 121
Whiterose Micro Cannula UC Medical 38
Monoject Cardinal Health 33
MagniCore Cook Incorporated 29
Breast localisation needle Möller Medical GmbH 29
CytoCut M.D.L. S.R.L. 28
Chiba Needle Marked Remington Medical, Inc. 26
Walcott Rx Products Psi/Eye-Ko, Inc. 24
Fine Needle Aspiration Mermaid Medical A/S 22
Coaxial Interventional Needle Itp Innovative Tomography Products GmbH 20

Showing 12 of 183. All products under Needle, Aspiration And Injection, Disposable

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