Duns Number:961027315
Device Description: PCNL, BTGH PACK
Catalog Number
SOT44PNHCC
Brand Name
CARDINAL HEALTH
Version/Model Number
SOT44PNHCC
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
PPE
Product Code Name
Nephroscope set
Public Device Record Key
c3b354ec-9db8-4dcd-9233-b7a00960ada4
Public Version Date
April 10, 2020
Public Version Number
1
DI Record Publish Date
April 02, 2020
Package DI Number
50888439571934
Quantity per Package
5
Contains DI Package
10888439571936
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 |