Duns Number:961027315
Device Description: IRRIGATION KIT
Catalog Number
SBA40IKCTA
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA40IKCTA
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
GBQ
Product Code Name
CATHETER, CONTINUOUS IRRIGATION
Public Device Record Key
3761c63a-41b9-47eb-97fa-9c2c9e804172
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
June 07, 2021
Package DI Number
50195594077370
Quantity per Package
10
Contains DI Package
10195594077372
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 |