Mixed Electrode Strip MS04R-IP10X-0JH

GUDID 00841823106773

AD-TECH MEDICAL INSTRUMENT CORPORATION

Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode

• Primary Device ID: 00841823106773
• NIH Device Record Key: 0f9ab6fb-0087-4df0-bbe3-d8f908260b96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixed Electrode Strip
• Version Model Number: MS04R-IP10X-0JH
• Catalog Number: MS04R-IP10X-0JH
• 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	00841823106773 [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