Identity
- Trade Name
- NEUWAVE FDA UDI
- Generic Name
- Microwave ablation system probe, non-powered FDA UDI
- Device Name
- Surgical Probe Kit FDA UDI
- Model / Reference
- PRSURGKT FDA UDI
- Description
- Surgical Probe Kit FDA UDI
Identifiers
- Catalog Number
- PRSURGKT FDA UDI
- Primary DI / UDI-DI
- 00853719006531 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system probe, non-powered 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
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
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Neuwave 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 |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
Sources (1)
- FDA UDI c68ae2cb-37a7-4900-aacf-4bc55adb2c60 37 fields · synced Jun 8, 2026