Medi-Trode Platinum

GUDID 00850689007780

2" x 3.5" Foam

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

• Primary Device ID: 00850689007780
• NIH Device Record Key: c737ddc0-8171-44f2-8e02-b6bc16e2a593
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medi-Trode Platinum
• Version Model Number: 202-094
• Company DUNS: 080930531
• Company Name: Compass Richmar, LLC
• Device Count: 1
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850689007780 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [Medi-Trode Platinum]

• 00850689007780: 2" x 3.5" Foam
• 00850689007773: 2"x 2" Foam
• 10850689007787: 2" x 3.5" Foam, Case of 10
• 10850689007770: 2"x 2" Foam, Case of 10