Device product
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Z-0204-2024
Product summary
- Firm
- Coapt LLC
- Event
- Event 93138
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 109 devices
- Official record key
device-enforcement:Z-0204-2024
Official wording
Reason: Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Code information: UDI/DI: +B618P1/$+202210P1603, All serial numbers
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden.
Derived failure modes
-
Unknown
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.