Cadwell Side-by-Side Bipolar Probe

Catalogue number 302429-000, listed by Cadwell Industries, Inc., United States, under Electrode, Needle. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26
4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GXZ
Manufacturer City Province Registered as Device types
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
Shenzhen Launch Electrical Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
BIO Protech Yantai Inc Yantai Shandong Manufacturer 12

Record

Regulatory record for Cadwell Side-by-Side Bipolar Probe
Listed by Cadwell Industries, Inc., United States
FDA product code GXZ
Device type Electrode, Needle
Device class Class 2
Regulation 21 CFR 882.1350
Establishment Specification developer, Manufacturer
510(k) K103128
Record published 2016-09-05
Record revised 2024-01-09 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature -10 to 50 °C
Packaging Pack of 10
Sizes Length 90 mm
Distribution end date 2024-01-01
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Cadwell Side-by-Side Bipolar Probe
Catalogue number Size Status
302429-000 Length 90 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rhythmlink® Rhythmlink International, LLC 204
Technomed Europe Technomed Engineering B.V. 114
Electrode, Needle Medtronic Xomed, Inc. 82
Horizon™ Rochester Electro Medical, Inc. 68
Spes Medica Subdermal Needle Electrodes Spes Medica Srl 66
Friendship Medical Xi’an Friendship Medical Electronics Co., Ltd. 66
Cadwell Technomed Engineering B.V. 61
The Electrode Store Impulse Technology LLC 56
Horizon™ LifeSync Corporation 55
Rochester Rochester Electro Medical, Inc. 41
Temena Temena GmbH 34
Cadwell Xi’an Friendship Medical Electronics Co., Ltd. 33

Showing 12 of 106. All products under Electrode, Needle

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