Subdural Electrode DG32A-SP10X-U00

GUDID 00841823101303

AD-TECH MEDICAL INSTRUMENT CORPORATION

Cortical electrode

• Primary Device ID: 00841823101303
• NIH Device Record Key: 72fef528-e145-439a-82e0-1e1a75a2da1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Subdural Electrode
• Version Model Number: DG32A-SP10X-U00
• Catalog Number: DG32A-SP10X-U00
• 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	00841823101303 [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 [Subdural Electrode]

• 00841823108456: ZS08R-GP10X-WW6
• 00841823108449: ZS04R-GP10X-WW6
• 00841823108388: VG05A-IS00X-0KQ
• 00841823108371: VG04A-SS00X-0KP
• 00841823108364: VG04A-IS00X-0KL
• 00841823108357: VG04A-IS00X-0KH
• 00841823108340: VG04A-IS00X-0KG
• 00841823108333: TS16R-SP10X-000
• 00841823108326: TS12R-SS10X-000
• 00841823108319: TS12R-SP10X-0E2
• 00841823108302: TS12R-SP10X-000
• 00841823108296: TS12R-SP05X-000
• 00841823108289: TS12R-AP10X-0W6
• 00841823108272: TS10R-SS10X-000
• 00841823108265: TS10R-SP10X-000
• 00841823108258: TS10R-AP10X-0W6
• 00841823108241: TS08R-SS10X-000
• 00841823108234: TS08R-SS05X-000
• 00841823108227: TS08R-SP10X-0T8
• 00841823108210: TS08R-SP10X-0P1
• 00841823108203: TS08R-SP10X-0E2
• 00841823108197: TS08R-SP10X-000
• 00841823108180: TS08R-AP10X-0W6
• 00841823108173: TS06R-SS10X-000
• 00841823108166: TS06R-SP10X-0T8
• 00841823108159: TS06R-SP10X-0T7
• 00841823108142: TS06R-SP10X-0P1
• 00841823108135: TS06R-SP10X-0E2
• 00841823108128: TS06R-SP10X-000
• 00841823108111: TS06R-IP10X-0H1
• 00841823108104: TS06R-AS10X-0W6
• 00841823108098: TS06R-AP10X-0WL
• 00841823108081: TS06R-AP10X-0W6
• 00841823108074: TS05R-SP10X-0T2
• 00841823108067: TS04R-SS15X-000
• 00841823108050: TS04R-SS10X-000
• 00841823108043: TS04R-SP15X-000
• 00841823108036: TS04R-SP10X-0T8
• 00841823108029: TS04R-SP10X-0P1
• 00841823108012: TS04R-SP10X-000
• 00841823108005: TS04R-SP05X-000
• 00841823107992: TS04R-AS10X-0W6
• 00841823107985: TS04R-AP10X-0W6
• 00841823107978: TS02R-SS10X-000
• 00841823107961: TS02R-SP10X-000
• 00841823107954: TS01R-SP00X-0W6
• 00841823107947: TG96P-MP03X-Z00
• 00841823107930: TG09A-MP03X-000
• 00841823107923: TG08A-MP03X-0JF
• 00841823107350: RS14R-SP05X-0WK