FDA UDI
In Commercial Distribution
🇺🇸 United States
ITE Transducer Arrays Large White Connector
DI: 07290107984201
·
Model: ITE1020W
·
Novocure GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ITE Transducer Arrays Large White Connector
- Primary DI
- 07290107984201
- Version / Model
- ITE1020W
- Catalog Number
- ITE1020WUS
- Company Name
- Novocure GmbH
- Labeler DUNS
- 486647295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 3
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 2f2668ba-a8ba-459b-aadc-3eecc0c58e0a
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SDA | Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | Unknown | 3 | |
| QGZ | Electrical Tumor Treatment Fields | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58846 | Alternating electric field antimitotic cancer treatment system transducer array | A sterile, disposable, head-worn component of an alternating electric field cancer treatment system designed to convert intermediate-frequency (100-300 kHz) alternating electric current to low-intensity alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Otherwise known as insulated field inducing electrodes (INE), the device is connected to an alternating current generator and consists of an array of ceramic discs contained in a plastic membrane, and is intended to be worn continuously for a period of 3-4 days before disposal. This is single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290107984201 | GS1 |
Customer Contacts
- Phone
- 1-855-281-9301
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H180002 | 003 |
| P100034 | 001 |
| P100034 | 002 |
| P100034 | 003 |
| P100034 | 004 |
| P100034 | 005 |
| P100034 | 006 |
| P100034 | 007 |
| P100034 | 008 |
| P100034 | 009 |
| P100034 | 010 |
| P100034 | 011 |
| P100034 | 012 |
| P230042 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- WEEE
- 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
- 35 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 27 Degrees Celsius