Cadwell Disposable Ground Electrode

GUDID 10840067100803

CADWELL INDUSTRIES, INC.

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium
Primary Device ID10840067100803
NIH Device Record Key06bd9cb6-3a20-4dc8-8432-aedb8a6bae87
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell Disposable Ground Electrode
Version Model Number302850-000-080
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com

Device Dimensions

Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter
Length2 Meter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067100806 [Primary]
GS110840067100803 [Package]
Contains: 00840067100806
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYELECTRODE, CUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-14
Device Publish Date2016-09-05

Devices Manufactured by CADWELL INDUSTRIES, INC.

00840067103517 - Cadwell Guardian2024-07-01 Input Extender Pod, Amplifier
00840067103524 - Cadwell Guardian2024-07-01 Input Extender Pod, TCS
00840067102879 - Cadwell Guiardian2024-03-12 Power Comm
00840067102886 - Cadwell Guiardian2024-03-12 Base
00840067102893 - Cadwell Guiardian2024-03-12 24-Channel Omni Amplifier
00840067102909 - Cadwell Guiardian2024-03-12 ES-10 Electrical Stimulator
00840067102916 - Cadwell Guiardian2024-03-12 SMX-32 Direct Cortical Mapping
00840067103609 - Cadwell Guiardian2024-03-12 AVX Auditory and Visual Stimulator

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.