Duns Number:184763290
Catalog Number
TS520L/A
Brand Name
Merit Medical®
Version/Model Number
00884450056424
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K915678,K915678,K915678
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
0d4acc37-9e1f-4935-aebf-cfc0d4c158d4
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884450056428
Quantity per Package
4
Contains DI Package
10884450056421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |