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
LHN System, Radiation Therapy, Charged-Particle, Medical

GMDN Terms

Code Name
47069 Proton therapy system

Identifiers

Type ID
Primary 05404013814015