Duns Number:961027315
Device Description: STERILE PERC NEPH PACK
Catalog Number
SOT31PNEVA
Brand Name
CARDINAL HEALTH
Version/Model Number
SOT31PNEVA
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
FGA
Product Code Name
Kit, nephroscope
Public Device Record Key
72e4c503-6611-4a37-a7f2-da0568f0fbca
Public Version Date
July 23, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2017
Package DI Number
50887488786900
Quantity per Package
2
Contains DI Package
10887488786902
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 |