Duns Number:961027315
Device Description: ORGAN DONATION PK
Catalog Number
SBA18ODAMB
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA18ODAMB
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
LRO
Product Code Name
General surgery tray (kit)
Public Device Record Key
d20cd1d3-3561-432a-98d8-c1c70c64b8c7
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
October 28, 2015
Package DI Number
50885425969249
Quantity per Package
1
Contains DI Package
00885425969244
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 |