Duns Number:961027315
Device Description: STERILE C SECTION TRAY
Catalog Number
SMA44CSMRC
Brand Name
CARDINAL HEALTH
Version/Model Number
SMA44CSMRC
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
OHM
Product Code Name
Cesarean section kit
Public Device Record Key
d90668df-c397-46fc-8749-6bfc14ab5112
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
August 31, 2015
Package DI Number
50885425937941
Quantity per Package
3
Contains DI Package
00885425937946
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 |