Duns Number:177655466
Catalog Number
-
Brand Name
Cardiovascular Procedure Kit
Version/Model Number
64162
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)
Yes
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
59491e1b-d35f-408e-9d81-60ce476986c8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 01, 2014
Package DI Number
50699753456230
Quantity per Package
5
Contains DI Package
00699753456235
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 Piece Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 174 |