Eagle Electrode Manufacturing Self Adhering Electrodes EEM2X4RCT

GUDID 00867991000231

2 inch by 4 inch electrodes for use with TENS, NMES, IFC, EMG devices

EAGLE ELECTRODE MANUFACTURING LLC

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00867991000231
• NIH Device Record Key: f1408e7e-8fcc-4157-a9f3-8818e9809157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eagle Electrode Manufacturing Self Adhering Electrodes
• Version Model Number: EEM2X4RCT
• Catalog Number: EEM2X4RCT
• Company DUNS: 071834627
• Company Name: EAGLE ELECTRODE MANUFACTURING 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com
• Phone: 866-486-3332
• Email: eric.reifer@eagleelectrode.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867991000231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030800

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [Eagle Electrode Manufacturing Self Adhering Electrodes]

• 00867991000231: 2 inch by 4 inch electrodes for use with TENS, NMES, IFC, EMG devices
• 00867991000224: 3 inch round electrodes for use with TENS, NMES, IFC, EMG devices
• 00867991000217: 2 inch round electrodes for use with TENS, NMES, IFC, EMG devices
• 00867991000200: 2 inch square electrodes for use with TENS, NMES, IFC, EMG devices