Identity
- Trade Name
- NovaSure FDA UDI
- Generic Name
- Tumour-therapy radio-frequency hyperthermia system FDA UDI
- Model / Reference
- NovaSure Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045500853 FDA UDI
- PMA Number
- P010013 FDA UDI
- FDA Product Code
- MNB FDA UDI
- GMDN Term
- Tumour-therapy radio-frequency hyperthermia system FDA UDI
Classification
- Device Class
- Class III 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
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
No
FDA UDI
Category: Tumour-therapy radio-frequency hyperthermia system
NovaSure by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tumour-therapy radio-frequency hyperthermia system.
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Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 65b1d9b8-24a1-4af9-85c4-ce8585dacf0a 33 fields · synced May 30, 2026