Cadwell Feld Pads

GUDID 00840067101681

CADWELL INDUSTRIES, INC.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode
Primary Device ID00840067101681
NIH Device Record Key61b366da-a050-4e04-8145-641850c43472
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell Feld Pads
Version Model Number302703-200
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count12
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067101681 [Primary]
GS110840067101688 [Unit of Use]

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 Number4
Public Version Date2019-04-15
Device Publish Date2016-09-05

Devices Manufactured by CADWELL INDUSTRIES, INC.

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
10840067101411 - Cadwell Disposable Disc Electrodes2024-01-09
00840067103890 - Cadwell2022-10-03 Ring Electrode with 20in lead attached length
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