FDA UDI In Commercial Distribution 🇺🇸 United States

Radiochromic.com

DI: B9876X00 · Model: 6.0 · RADIOCHROMIC SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Radiochromic.com
Primary DI
B9876X00
Version / Model
6.0
Company Name
RADIOCHROMIC SL.
Labeler DUNS
468141103
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-09
Public Version
1
Public Version Date
2025-12-17
Public Version Status
New
Public Device Record Key
86927ee7-bb71-4b93-9d8d-d02ffffccbb6

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
40887 Radiation therapy software

Identifiers

Type ID
Primary B9876X00