FDA UDI In Commercial Distribution 🇺🇸 United States

RayStation

DI: 07350002010082 · Model: 6.1.1 · Raysearch Laboratories AB (Publ)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RayStation
Primary DI
07350002010082
Version / Model
6.1.1
Company Name
Raysearch Laboratories AB (Publ)
Labeler DUNS
355977901
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-30
Public Version
2
Public Version Date
2023-05-18
Public Version Status
Update
Public Device Record Key
2be38a85-801c-47b1-a4cf-9be202d05633

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
No
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
MUJ System, Planning, Radiation Therapy Treatment

GMDN Terms

Code Name
40887 Radiation therapy software

Identifiers

Type ID
Primary 07350002010082