Duns Number:360624720
Device Description: VersaSafe Plastic Cannula
Catalog Number
9391-0200
Brand Name
VersaSafe
Version/Model Number
9391-0200
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
0d1cfa2d-f53d-44a9-8f85-f58daea3cc5c
Public Version Date
April 27, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
37613203009523
Quantity per Package
6
Contains DI Package
27613203033613
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |