FDA UDI
In Commercial Distribution
🇺🇸 United States
Proteus 235
DI: 05404013814015
·
Model: Proteus PLUS
·
Ion Beam Applications SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Proteus 235
- Primary DI
- 05404013814015
- Version / Model
- Proteus PLUS
- Catalog Number
- NA
- Company Name
- Ion Beam Applications SA
- Labeler DUNS
- 372078154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 1
- Public Version Date
- 2018-09-03
- Public Version Status
- New
- Public Device Record Key
- ada9758b-078c-4ccc-b5fa-b4f617d78392
Device Description
IBA Proton Therapy System – Proteus 235
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 |
|---|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47069 | Proton therapy system | An assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05404013814015 | GS1 |