FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Optune Porteable Battery Rack
DI: 07290107980289
·
Model: PBR9000
·
NOVOCURE (ISRAEL) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optune Porteable Battery Rack
- Primary DI
- 07290107980289
- Version / Model
- PBR9000
- Catalog Number
- 90039
- Company Name
- NOVOCURE (ISRAEL) LTD
- Labeler DUNS
- 532457256
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 4
- Public Version Date
- 2019-04-24
- Public Version Status
- Update
- Public Device Record Key
- 3c79cb01-2ee8-4e53-bde0-711dafae03d7
- Distribution End Date
- 2019-04-23
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07290107980289 | GS1 |
Customer Contacts
- Phone
- 1-855-281-9301
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100034 | 001 |
| P100034 | 002 |
| P100034 | 003 |
| P100034 | 004 |
| P100034 | 005 |
| P100034 | 006 |
| P100034 | 007 |
| P100034 | 008 |
| P100034 | 009 |
| P100034 | 010 |
| P100034 | 011 |
| P100034 | 012 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep indoors
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile - handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from extreme heat and sources of radiation
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius