Duns Number:961027315
Device Description: IUS PERC 1 PK
Catalog Number
SBACGPPMEA
Brand Name
CARDINAL HEALTH
Version/Model Number
SBACGPPMEA
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
PPE
Product Code Name
Nephroscope set
Public Device Record Key
d1b9a684-865d-41b7-bbde-ff8d4f7341d3
Public Version Date
January 10, 2019
Public Version Number
1
DI Record Publish Date
December 10, 2018
Package DI Number
50888439261057
Quantity per Package
2
Contains DI Package
10888439261059
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 |