Duns Number:961027315
Device Description: CARDIAC CATH TRAY SNVMC
Catalog Number
SAN16CCSHC
Brand Name
CARDINAL HEALTH
Version/Model Number
SAN16CCSHC
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"
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
OES
Product Code Name
Cardiac catheterization kit
Public Device Record Key
2e2fa87d-34ef-4dc1-a711-d26c3079d250
Public Version Date
August 13, 2020
Public Version Number
1
DI Record Publish Date
August 05, 2020
Package DI Number
50888439843741
Quantity per Package
2
Contains DI Package
10888439843743
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |