COTRAC

GUDID 00650551146506

CORTAC GRID ELECTRODE, PLATINUM, 20 MACRO CONTACTS, 4X5 #1 RADIOPLAQUE TEXTURED INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 EXITS

PMT CORPORATION

Cortical electrode

• Primary Device ID: 00650551146506
• NIH Device Record Key: e80f3bec-5cf2-4879-94ee-59c468ea41d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COTRAC
• Version Model Number: 2110TX-20-086
• 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	00650551146506 [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: 2020-05-11
• Device Publish Date: 2020-05-01

Devices Manufactured by PMT CORPORATION

• 00650551003717 - Integra: 2022-08-16 TE OVAL, SMOOTH, 2-STAGE, MICRO PORT TUBING, 370CC FILL, PROJECTION 10CM, 5X10CM
• 00650551002758 - ALLURA: 2021-11-04 VAGINAL STENT, TAPERED CYLINDRICAL, 4 SUTURE TABS "X" LOCATION, 4X12CM, 4CM PROJECTION, 115CC FILL
• 00650551002611 - Spetzler MacroVac®: 2021-11-02 09 FRENCH, TEARDROP TIP, 4.5" LENGTH, SATIN FINISH
• 00650551002642 - DEPTHALON: 2021-11-02 SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDI
• 00650551002659 - DEPTHALON: 2021-11-02 SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDI
• 00650551002703 - PMT CORPORATION: 2021-11-02 2.1MM SPLIT BUSHING FOR ROSA SEEG DEPTH PLACEMENT
• 00650551002420 - Integra: 2021-10-29 BE TEARDROP, SMOOTH, SINGLE STAGE, INTERNAL PORT, 10X13 CM SIZE, 450CC FILL, 7.5 PROJECTION
• 00650551002512 - Spetzler MacroVac®: 2021-10-29 10 FRENCH, MEDIUM TIP, 3" LENGTH, SATIN FINISH