Duns Number:961027315
Device Description: Indicator Tape 1 in. x 60 yd.
Catalog Number
T40311LF
Brand Name
CARDINAL HEALTH
Version/Model Number
T40311LF
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122555,K122555
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
73f2fe1b-4279-48ac-b91e-fbefdce7d013
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
October 04, 2016
Package DI Number
50885380120174
Quantity per Package
36
Contains DI Package
10885380120176
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 |