FDA UDI Not in Commercial Distribution 🇺🇸 United States

Radiochromic.com

DI: B9875X10 · Model: 5.1 · RADIOCHROMIC SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Radiochromic.com
Primary DI
B9875X10
Version / Model
5.1
Company Name
RADIOCHROMIC SL.
Labeler DUNS
468141103
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-06-10
Public Version
2
Public Version Date
2025-12-10
Public Version Status
Update
Public Device Record Key
906a7dc9-c162-4ced-9c75-f2a1a26abb89
Distribution End Date
2025-12-09

Device Description

Radiochromic film dosimetry and radiation therapy QA software

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MWW Accessory - Film Dosimetry System

GMDN Terms

Code Name
38399 Accelerator system quality assurance device

Identifiers

Type ID
Primary B9875X10