Identity
- Trade Name
- Horizon™ FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 1.5 M SINGLE LEADWIRE, COLOR GROUP A - 24/Box FDA UDI
- Model / Reference
- NS-S94015-A-24 FDA UDI
- Description
- DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 1.5 M SINGLE LEADWIRE, COLOR GROUP A - 24/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593008730 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Horizon™ by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI cb7c8e6b-ea2a-4ede-b95d-b1b9f99edce0 35 fields · synced May 30, 2026