Microwire Cortac

GUDID 00650551144021

Subdural Grid Electrode, 16 Microwires, 4x4 Inline Connector, 1 Exit

PMT CORPORATION

Cortical electrode

• Primary Device ID: 00650551144021
• NIH Device Record Key: fb76c162-b768-4a7e-b5c2-432d6d017848
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microwire Cortac
• Version Model Number: 2112-00-16-028
• Company DUNS: 039576871
• Company Name: PMT 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551144021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082474

FDA Product Code

• GYC: Electrode, Cortical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [Microwire Cortac]

• 00650551144038: Subdural Grid Electrode, 16 Microwires, 4x4 Inline Connector, 1 Exit, Non sterile
• 00650551144021: Subdural Grid Electrode, 16 Microwires, 4x4 Inline Connector, 1 Exit
• 00650551146704: CORTAC GRID ELECTRODE, PLATINUM, 189 MICRO CONTACTS, 4x4 INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 EX