Identity
- Trade Name
- NEUWAVE EUDAMEDFDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- NEUWAVE Surgical PDM Mount, CT Bed Rail Mounts EUDAMEDCT Bed Rail Mount, GE/Philips FDA UDI
- Model / Reference
- CTBKT1 EUDAMEDFDA UDI
- Description
- CT Bed Rail Mount, GE/Philips FDA UDI
Identifiers
- Catalog Number
- CTBKT1 FDA UDI
- Primary DI / UDI-DI
- 00853719006456 EUDAMEDFDA UDI
- Basic UDI-DI
- 081891302a0047K EUDAMED
- Direct Marketing DI
- 00853719006456 EUDAMED
- FDA Product Code
- BWN FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Width — 501 Millimeter FDA UDIDepth — 57 Millimeter FDA UDI
Neuwave by NeuWave Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081891302a0047K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9338573a-0870-478f-9f15-bf6cc1df98ba 61 fields · synced Jun 8, 2026
- FDA UDI a66177cd-6bec-4251-8775-d71a6cb144b6 37 fields · synced May 30, 2026