Duns Number:017246562
Catalog Number
-
Brand Name
Centurion
Version/Model Number
SA3720HKI
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OES
Product Code Name
Cardiac catheterization kit
Public Device Record Key
3dba52a4-cb33-4f51-a058-674a162aac3e
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 14, 2016
Package DI Number
00653160247145
Quantity per Package
5
Contains DI Package
10653160247142
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |