Duns Number:690724240
Catalog Number
-
Brand Name
Supercath 5
Version/Model Number
SP120-18-31T
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190001,K190001,K190001
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
6e3803e4-9562-4a1e-aea6-1951311f4912
Public Version Date
March 31, 2022
Public Version Number
5
DI Record Publish Date
February 09, 2018
Package DI Number
14543527242544
Quantity per Package
50
Contains DI Package
04543527242547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 211 |