Duns Number:809699023
Device Description: Vaxcel Mini Stick Kit Coaxial Dilator Set
Catalog Number
-
Brand Name
Vaxcel
Version/Model Number
45987
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K974640,K974640
Product Code
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
60de6369-790f-4643-b9da-dab85f20f285
Public Version Date
August 13, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
M001459871
Quantity per Package
10
Contains DI Package
M001459870
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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |