Duns Number:051244569
Device Description: CMS9000 Digital Recording System
Catalog Number
CMS9000
Brand Name
CMS9000
Version/Model Number
CMS9000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 2019
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMB
Product Code Name
Device, Digital Image Storage, Radiological
Public Device Record Key
6dfe5409-39b3-4259-8087-ad055b3563e0
Public Version Date
June 15, 2022
Public Version Number
4
DI Record Publish Date
July 12, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 86 |