FDA UDI In Commercial Distribution 🇺🇸 United States

CDR DICOM

DI: D764B10301910 · Model: B1030191 · SIRONA DENTAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CDR DICOM
Primary DI
D764B10301910
Version / Model
B1030191
Company Name
SIRONA DENTAL, INC.
Labeler DUNS
078613913
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
5
Public Version Date
2022-12-09
Public Version Status
Update
Public Device Record Key
952027cc-1c4d-4fd2-9f53-e86aefb113b7

Device Description

CDR DICOM 5.0 FOR WINDOWS 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
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
EAP Unit, X-Ray, Intraoral

GMDN Terms

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

Identifiers

Type ID
Primary D764B10301910

Customer Contacts