Duns Number:961027315
Device Description: Cardinal Health Lukens Tube 20CC, 6 1/4"
Catalog Number
19510-065
Brand Name
CARDINAL HEALTH
Version/Model Number
19510-065
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
BYZ
Product Code Name
TRAP, STERILE SPECIMEN
Public Device Record Key
57e38ea7-0ee7-490d-a454-96d8538cbd75
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2017
Package DI Number
20885380138239
Quantity per Package
12
Contains DI Package
10885380138232
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |