Identity
- Trade Name
- Horizon™ FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 1.5 M SINGLE LEADWIRE, COLOR GROUP A - 24/BOX FDA UDI
- Model / Reference
- NS-S91615-A-24 FDA UDI
- Description
- DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 1.5 M SINGLE LEADWIRE, COLOR GROUP A - 24/BOX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593009072 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 |
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Manufacturer
- Manufacturer
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI e144083f-2c67-401c-a123-93d548a84b18 35 fields · synced May 29, 2026