Karatrode

GUDID 80092237900839

2" Round Cloth

Compass Richmar, LLC

Transcutaneous electrical stimulation electrode
Primary Device ID80092237900839
NIH Device Record Keybbf0dd9e-c437-49dc-8699-8906cec861a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaratrode
Version Model Number203-340
Company DUNS080930531
Company NameCompass Richmar, LLC
Device Count4
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100092237900833 [Primary]
GS101092237900832 [Unit of Use]
GS130092237900834 [Package]
Contains: 00092237900833
Package: Inner Carton [10 Units]
In Commercial Distribution
GS180092237900839 [Package]
Contains: 30092237900834
Package: Master carton [50 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-19

On-Brand Devices [Karatrode]

300922379008723" Round Cloth
800922379008602"x 3.5" Cloth
800922379008532"x 2" Cloth
800922379008462"x 2" Foam
800922379008392" Round Cloth
008506890076433" Round Cloth
008506890076362"x 3.5" Cloth
008506890076292"x 2" Cloth
008506890076122"x 2" Foam
008506890076052" Round Cloth
108506890076403" Round Cloth, Case of 10
108506890076332"x 3.5" Cloth, Case of 10
108506890076262"x 2" Cloth, Case of 10
108506890076192"x 2" Foam, Case of 10
108506890076022" Round Cloth, Case of 10

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