Duns Number:184763290
Catalog Number
CENP27C
Brand Name
Centros®
Version/Model Number
00884450242032
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
39a96af1-f2d8-4588-871e-f900e4af15f4
Public Version Date
October 11, 2021
Public Version Number
5
DI Record Publish Date
October 31, 2015
Package DI Number
10884450242039
Quantity per Package
1
Contains DI Package
00884450242032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |