Duns Number:174262477
Catalog Number
-
Brand Name
STRADIS HEALTHCARE
Version/Model Number
682-1660R1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
OEZ
Product Code Name
Cardiovascular Procedure Kit
Public Device Record Key
315b00cc-bc36-4383-a74c-f711c849e3be
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 21, 2022
Package DI Number
M7526821660R11
Quantity per Package
5
Contains DI Package
M7526821660R10
Package Discontinue Date
-
Package Status
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 | 1226 |
2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
U | Unclassified | 10 |