Cadwell Disposable Disc Electrodes

GUDID 20840067101418

CADWELL INDUSTRIES, INC.

Electrode conductive medium
Primary Device ID20840067101418
NIH Device Record Key6f71e513-0426-4f7a-89f3-ef092fa0504b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell Disposable Disc Electrodes
Version Model Number302291-000
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 Datefalse
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(800)245-3001
Emailservice@cadwell.com

Device Dimensions

Outer Diameter0.75 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067101414 [Primary]
GS110840067101411 [Package]
Contains: 00840067101414
Package: Box [20 Units]
In Commercial Distribution
GS120840067101418 [Package]
Contains: 10840067101411
Package: Case [12 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 Number4
Public Version Date2018-10-22
Device Publish Date2016-09-05

On-Brand Devices [Cadwell Disposable Disc Electrodes]

20840067101418302291-000
20840067101401302290-000
10840067101411302291-000

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