Identity
- Trade Name
- Alpha FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Alpha Control Liner Medium, 10 cm Leads FDA UDI
- Model / Reference
- ACL-049-M10 FDA UDI
- Description
- Alpha Control Liner Medium, 10 cm Leads FDA UDI
Identifiers
- Catalog Number
- ACL-049-M10 FDA UDI
- Primary DI / UDI-DI
- 00194711116539 FDA UDI
- 510(k) Number
- K223738 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
Yes
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
No
FDA UDI
Category: Analytical non-scalp cutaneous electrode
Alpha by WillowWood Global LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223738 also covers:
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
- Alpha — WillowWood Global LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WillowWood Global LLC
Sources (1)
- FDA UDI 0430c4bd-a4e4-4a07-a5e5-73bf38f9214c 36 fields · synced May 30, 2026