FDA UDI In Commercial Distribution 🇺🇸 United States

CS Orthodontic Imaging Software

DI: 60889971746832 · Model: CS Orthodontic Imaging Software · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CS Orthodontic Imaging Software
Primary DI
60889971746832
Version / Model
CS Orthodontic Imaging Software
Catalog Number
1746833
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
aefa0cd4-3d79-45fa-93de-03735a1e21fc

Device Description

CS Orthodontic Imaging Software

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
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
LLZ System, image processing, radiological

GMDN Terms

Code Name
58473 Diagnostic x-ray digital imaging system workstation application software

Identifiers

Type ID
Primary 60889971746832