Identity
- Trade Name
- NEUWAVE EUDAMEDFDA UDI
- Generic Name
- Microwave ablation system probe, non-powered FDA UDI
- Device Name
- NEUWAVE Ablation Probe EUDAMEDNEUWAVE PRS Probe 15CM 15ga FDA UDI
- Model / Reference
- PRS15 EUDAMEDFDA UDI
- Description
- NEUWAVE PRS Probe 15CM 15ga FDA UDI
Identifiers
- Catalog Number
- PRS15 FDA UDI
- Primary DI / UDI-DI
- 00818913020509 EUDAMEDFDA UDI
- Basic UDI-DI
- 081891302a0037H EUDAMED
- 510(k) Number
- K200081 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Microwave ablation system probe, non-powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Neuwave by NeuWave Medical, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081891302a0037H | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
- EUDAMED SRN
- US-MF-000016783
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED ca355514-90d6-44e6-9be4-b4b4dc8d3c2f 61 fields · synced Jun 8, 2026
- FDA UDI d81891aa-63f5-4057-b491-9d84b9ba005f 37 fields · synced May 30, 2026