Identity
- Trade Name
- Hilger Dual Stim FDA UDI
- Generic Name
- Facial nerve-locating system FDA UDI
- Model / Reference
- 3900 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00702173139005 FDA UDI
- 510(k) Number
- K063560 FDA UDI
- FDA Product Code
- ETN FDA UDI
- GMDN Term
- Facial nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
No
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: Facial nerve-locating system
Hilger Dual Stim by WR Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Facial nerve-locating system.
- One RF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- One RF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Silverstein Facial Nerve Stimulator — WR Medical Electronics Co. · Class II
Cleared under the same submission
K063560 also covers:
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
- WR Medical Electronics Co.
Sources (1)
- FDA UDI c9f8c5fb-2d5f-47c3-ae63-bd866aa6723e 34 fields · synced Jun 8, 2026