Duns Number:961027315
Device Description: T-TUBE 19FR SILICONE
Catalog Number
SU130-1334
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-1334
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 30, 2024
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
5a15471f-cacc-41f8-b976-3e64a46fa43d
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
May 01, 2018
Package DI Number
50630140034532
Quantity per Package
8
Contains DI Package
20630140034531
Package Discontinue Date
October 30, 2024
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 |