Identity
- Trade Name
- Optune Lua Power Supply FDA UDI
- Generic Name
- Alternating electric field antimitotic cancer treatment system generator FDA UDI
- Model / Reference
- SPS9200 FDA UDI
Identifiers
- Catalog Number
- SPS9200US FDA UDI
- Primary DI / UDI-DI
- 07290107983228 FDA UDI
- FDA Product Code
- QGZ FDA UDISDA FDA UDI
- GMDN Term
- Alternating electric field antimitotic cancer treatment system generator 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating electric field antimitotic cancer treatment system generator
Optune Lua Power Supply by Novocure Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
H180002 also covers:
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- Connection Cable for NovoTTF-100L — NOVOCURE INC
- ILE Transducer Arrays Large Black Connector — NOVOCURE INC
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- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
P230042 also covers:
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery Charger for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- Battery for Optune Lua — NOVOCURE INC
- ILE Transducer Arrays Large Black Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
- ILE Transducer Arrays Large White Connector — NOVOCURE INC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novocure Inc
Sources (1)
- FDA UDI 4e1c5478-d687-4fe2-9cbb-18825edcfcd0 36 fields · synced May 31, 2026