FDA UDI In Commercial Distribution 🇺🇸 United States

CANON INC.

DI: 04549292075175 · Model: CSX-30 · CANON INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CANON INC.
Primary DI
04549292075175
Version / Model
CSX-30
Company Name
CANON INC.
Labeler DUNS
695138065
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-03-14
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
783849e2-4af5-4ee5-b4c4-a582dceb881b

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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

GMDN Terms

Code Name
37679 Stationary general-purpose fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary 04549292075175

Premarket Submissions

Submission Number Supplement Number
K162909 000