FDA UDI In Commercial Distribution 🇺🇸 United States

ArtPIX DRF

DI: 07290012104909 · Model: 63627589 · C.M.T. MEDICAL TECHNOLOGIES LTD.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ArtPIX DRF
Primary DI
07290012104909
Version / Model
63627589
Company Name
C.M.T. MEDICAL TECHNOLOGIES LTD.
Labeler DUNS
600084453
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-18
Public Version
1
Public Version Date
2020-10-26
Public Version Status
New
Public Device Record Key
b8bac88d-f280-4dd8-a06c-35929f530437

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 07290012104909

Premarket Submissions

Submission Number Supplement Number
K202235 000