Duns Number:371618773
Catalog Number
-
Brand Name
Clinical review 2MP
Version/Model Number
MDRC-2122 WP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 15, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMD
Product Code Name
System, digital image communications, radiological
Public Device Record Key
230612f7-ad25-4c75-9dcf-0ea14f431e00
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
June 30, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 105 |
2 | A medical device with a moderate to high risk that requires special controls. | 259 |