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ControlSeal Electrode Domes (Standard Size)
FDA UDIClass II (US FDA UDI)
by Coapt, LLC
Identity
- Trade Name
- ControlSeal Electrode Domes (Standard Size) FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618E2 FDA UDI
- 510(k) Number
- K223605 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analytical non-scalp cutaneous electrode
ControlSeal Electrode Domes (Standard Size) by Coapt, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Coapt, LLC
Sources (1)
- FDA UDI 9c5e7447-3542-4210-b283-3fcf942836b5 34 fields · synced Jun 8, 2026