Identity
- Trade Name
- Horizon™ FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 2 20 Pairs/Box FDA UDI
- Model / Reference
- NS-S82015-PT2-20RM FDA UDI
- Description
- DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 2 20 Pairs/Box FDA UDI
Identifiers
- Catalog Number
- NS-S82015-PT2-20RM FDA UDI
- Primary DI / UDI-DI
- 00849593009638 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
- 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
Category: Subdermal needle electrode
Horizon™ by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subdermal needle electrode.
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Neuroline Twisted Pair SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
- Neuroradium — Technomed Engineering B.V. · Class II
- Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
- Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
- Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
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 018b4d71-fd0f-412b-89c5-909c28626f0a 35 fields · synced Jun 8, 2026