Duns Number:961027315
Device Description: KIT,C SECTION WOMEN CHILDREN
Catalog Number
PL23SCM12
Brand Name
CARDINAL HEALTH
Version/Model Number
PL23SCM12
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
OHM
Product Code Name
Cesarean section tray
Public Device Record Key
c95e5833-ebb1-4289-bc73-aa2fd9a36383
Public Version Date
March 18, 2021
Public Version Number
1
DI Record Publish Date
March 10, 2021
Package DI Number
50195594966766
Quantity per Package
2
Contains DI Package
10195594966768
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 |