FDA UDI
In Commercial Distribution
🇺🇸 United States
Optune Lua Power Supply
DI: 07290107983099
·
Model: SPS9200
·
Novocure GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optune Lua Power Supply
- Primary DI
- 07290107983099
- Version / Model
- SPS9200
- Catalog Number
- SPS9200US
- Company Name
- Novocure GmbH
- Labeler DUNS
- 486647295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-18
- Public Version
- 2
- Public Version Date
- 2023-01-09
- Public Version Status
- Update
- Public Device Record Key
- 56f98bcc-e5be-44cd-b3f7-39de11a2d03d
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGZ | Electrical Tumor Treatment Fields | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58847 | Alternating electric field antimitotic cancer treatment system generator | A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290107983099 | GS1 |
Customer Contacts
- Phone
- 1-855-281-9301
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H180002 | 000 |
| H180002 | 001 |
| H180002 | 002 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from extreme heat and sources of radiation
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile - handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- WEEE