Duns Number:017415781
Device Description: The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline bulb on each end of a flexible shaft. The bulbs are of different size on each end of the Vascular Probe.
Catalog Number
7151520ES
Brand Name
Vascular Probe Extra Supple
Version/Model Number
7151520ES
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
K130896,K130896
Product Code
DWP
Product Code Name
DILATOR, VESSEL, SURGICAL
Public Device Record Key
75b224d2-5aa5-41db-b59e-1d8e27e9329a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50085412532658
Quantity per Package
5
Contains DI Package
00085412532653
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |