Provox® Vega™ Plug - The Provox Vega Plug is a first-aid tool for - Atos Medical AB

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.

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More Product Details

Catalog Number

8119

Brand Name

Provox® Vega™ Plug

Version/Model Number

17 Fr

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EWL

Product Code Name

Prosthesis, Laryngeal (Taub)

Device Record Status

Public Device Record Key

344a63b2-dab7-4191-9f32-563345a21ecb

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATOS MEDICAL AB" Characteristics
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