Mixed Electrode Strip MS04N-LP10X-0JF

GUDID 00841823106759

AD-TECH MEDICAL INSTRUMENT CORPORATION

Cortical electrode

• Primary Device ID: 00841823106759
• NIH Device Record Key: 8daab838-2034-41ab-b921-83d3dc8c0e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixed Electrode Strip
• Version Model Number: MS04N-LP10X-0JF
• Catalog Number: MS04N-LP10X-0JF
• Company DUNS: 174813410
• Company Name: AD-TECH MEDICAL INSTRUMENT CORPORATION
• 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: true
• 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(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841823106759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053363

FDA Product Code

• GYC: ELECTRODE, CORTICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Mixed Electrode Strip]

• 00841823106780: MS04R-IP10X-0T7
• 00841823106773: MS04R-IP10X-0JH
• 00841823106766: MS04R-IP10X-000
• 00841823106759: MS04N-LP10X-0JF
• 00841823106742: MS02R-IP10X-000