Duns Number:961027315
Device Description: STR OB VAGINAL DELIVERY PK
Catalog Number
SMA38VDHHB
Brand Name
CARDINAL HEALTH
Version/Model Number
SMA38VDHHB
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
MLS
Product Code Name
Labor and Delivery Kit
Public Device Record Key
51d6b8b9-3439-4941-b88b-4e4ba1dcb911
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
July 01, 2016
Package DI Number
50885425647512
Quantity per Package
12
Contains DI Package
10885425647514
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 |