Duns Number:961027315
Device Description: STERILE 1X6 TEFLON FELT KIT
Catalog Number
SID23TFCSB
Brand Name
CARDINAL HEALTH
Version/Model Number
SID23TFCSB
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
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
74f790e6-0ba7-4fb5-9bfe-06138c4f5e76
Public Version Date
July 17, 2018
Public Version Number
3
DI Record Publish Date
September 18, 2015
Package DI Number
50885425282706
Quantity per Package
50
Contains DI Package
00885425282701
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 |