Duns Number:355470923
Device Description: The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve.
Catalog Number
8139
Brand Name
Provox® Vega™ Plug
Version/Model Number
22.5 Fr
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K940638
Product Code
EWL
Product Code Name
Prosthesis, Laryngeal (Taub)
Public Device Record Key
921666df-d667-4936-acfe-e2fa36a28f6b
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |