FDA UDI
In Commercial Distribution
🇺🇸 United States
NovoTAL flex
DI: 07290107984447
·
Model: SW000128
·
Novocure GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NovoTAL flex
- Primary DI
- 07290107984447
- Version / Model
- SW000128
- Catalog Number
- SW000128
- Company Name
- Novocure GmbH
- Labeler DUNS
- 486647295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-05
- Public Version
- 2
- Public Version Date
- 2025-02-27
- Public Version Status
- Update
- Public Device Record Key
- dd92e4ca-75bb-4876-becb-0e922962c394
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NZK | Stimulator, Low Electric Field, Tumor Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58845 | Alternating electric field antimitotic cancer treatment system | An assembly of portable devices designed to apply low-intensity, intermediate-frequency (100-300 kHz) alternating electric fields 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) and is intended to destroy rapidly dividing cells with little effect on normal cells. The system primarily consists of a battery-powered alternating-current generator, a disposable transducer array, a battery pack, and a battery charger. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290107984447 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100034 | 033 |