Duns Number:809699023
Device Description: Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Dilator, NiTi Guidewi Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Dilator, NiTi Guidewire, and Radiopaque Tip
Catalog Number
-
Brand Name
Vaxcel
Version/Model Number
45991
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"
-
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
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
63be65ee-0246-4f4e-937c-7e46bb2d83f1
Public Version Date
August 13, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2015
Package DI Number
M001459911
Quantity per Package
10
Contains DI Package
M001459910
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 |