Duns Number:933762262
Device Description: PMD Viewer Software
Catalog Number
12143
Brand Name
PMD Viewer
Version/Model Number
PMD Viewer
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092204
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
f99dbe65-678e-4bcf-a6f2-462bd2a80e7f
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
November 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |