Karatrode

GUDID 80092237900860

2"x 3.5" Cloth

Compass Richmar, LLC

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 80092237900860
• NIH Device Record Key: 021856c3-a791-465e-a3f6-118b9ede8414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karatrode
• Version Model Number: 203-336
• Company DUNS: 080930531
• Company Name: Compass Richmar, LLC
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-4945
• Email: customerservice@richmarweb.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092237900864 [Primary]
GS1	01092237900863 [Unit of Use]
GS1	30092237900865 [Package]; Contains: 00092237900864; Package: inner carton [10 Units]; In Commercial Distribution
GS1	80092237900860 [Package]; Contains: 30092237900865; Package: master Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050469

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-19

On-Brand Devices [Karatrode]

• 30092237900872: 3" Round Cloth
• 80092237900860: 2"x 3.5" Cloth
• 80092237900853: 2"x 2" Cloth
• 80092237900846: 2"x 2" Foam
• 80092237900839: 2" Round Cloth
• 00850689007643: 3" Round Cloth
• 00850689007636: 2"x 3.5" Cloth
• 00850689007629: 2"x 2" Cloth
• 00850689007612: 2"x 2" Foam
• 00850689007605: 2" Round Cloth
• 10850689007640: 3" Round Cloth, Case of 10
• 10850689007633: 2"x 3.5" Cloth, Case of 10
• 10850689007626: 2"x 2" Cloth, Case of 10
• 10850689007619: 2"x 2" Foam, Case of 10
• 10850689007602: 2" Round Cloth, Case of 10