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

• 00650551005391 - INTEGRA®: 2025-04-03 Integra TE, Enhanced Surface, Internal Port, Rectangle, 1000cc, 8x14cm, Suture Tabs
• 00650551002086 - PMT® SUCTION INSTRUMENTS: 2025-03-27 MALLEABLE SURGICAL SUCTION 6 FRENCH, 225MM LENGTH
• 00650551002093 - PMT® SUCTION INSTRUMENTS: 2025-03-27 MALLEABLE SURGICAL SUCTION 8 FRENCH, 225MM LENGTH
• 00650551002154 - INTEGRA®: 2025-03-27 BREAST EXPANDER, WIDE BASE OVAL SHAPE, SMOOTH SURFACE, INTERNAL PORT, 2-STAGE, SUTURE TABS, 12X10CM, 450CC FILL VOLUME, 9CM PROJ
• 00650551002161 - INTEGRA®: 2025-03-27 TE ROUND SHAPE, SMOOTH SURFACE, MICRO INTERNAL PORT, 1 SUTURE TAB, 12.5X12.5CM, 600CC FILL, 9.5CM PROJECTION
• 00650551002772 - INTEGRA®: 2025-03-27 TE RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT, SUTURE TABS, 8X18cm, 1450cc FILL, 12cm PROJECTION
• 00650551002833 - INTEGRA®: 2025-03-27 BE ROUND, SMOOTH, SINGLE STAGE, RESEAL INTERNAL PORT, SUTURE TABS, 14.6x14.6 CM, 700CC FILL, 6.7CM PROJECTION
• 00650551002932 - ALLURA®: 2025-03-27 VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X14CM, 4CM PROJECTION, 140CC FILL