Duns Number:828611934
Catalog Number
-
Brand Name
Medex
Version/Model Number
MX152072
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 23, 2020
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
Yes
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
8e9f7790-78fc-4413-b0ae-62887df24e16
Public Version Date
November 19, 2020
Public Version Number
5
DI Record Publish Date
October 11, 2016
Package DI Number
50351688509930
Quantity per Package
75
Contains DI Package
10351688509932
Package Discontinue Date
October 23, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |