Duns Number:355470923
Device Description: The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox
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 |