FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraBionic P1
DI: 04251867200072
·
Model: THBC P1 1.1-US-HDE
·
TheraBionic GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TheraBionic P1
- Primary DI
- 04251867200072
- Version / Model
- THBC P1 1.1-US-HDE
- Catalog Number
- THBC P1 1.1-US-HDE
- Company Name
- TheraBionic GmbH
- Labeler DUNS
- 312894281
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-09
- Public Version
- 1
- Public Version Date
- 2024-02-19
- Public Version Status
- New
- Public Device Record Key
- 87616896-6c76-4240-8307-41868f278f43
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| QOM | Stimulator, Electric Field, Intrabuccal |
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 | 04251867200072 | GS1 |
Customer Contacts
- Phone
- 312 286 4703
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H220001 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1200 millibar
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius