Duns Number:017246562
Catalog Number
-
Brand Name
Centurion
Version/Model Number
EGW4001ST
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
OFD
Product Code Name
Catheter introducer kit
Public Device Record Key
36b7af57-42f5-4111-9e8c-bf139cdb5815
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 12, 2016
Package DI Number
00653160267013
Quantity per Package
10
Contains DI Package
20653160267017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
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 |