Identity
- Trade Name
- Certus® 140 FDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- Footswitch, 4M, Gen1 FDA UDI
- Model / Reference
- 2.45 GHz Ablation System FDA UDI
- Description
- Footswitch, 4M, Gen1 FDA UDI
Identifiers
- Catalog Number
- DR-000489 FDA UDI
- Primary DI / UDI-DI
- 00853719006210 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Certus® 140 by NeuWave Medical, Inc. — 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
- NeuWave Medical, Inc.
Sources (1)
- FDA UDI eb567f01-f056-41f6-8436-53272922ad79 37 fields · synced Jun 8, 2026