Provox® Vega™ XtraSeal™ - Provox Vega voice prosthesis is an indwelling, - Atos Medical AB

Duns Number:355470923

Device Description: Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended fo Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis.

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More Product Details

Catalog Number

7787

Brand Name

Provox® Vega™ XtraSeal™

Version/Model Number

22.5 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090455

Product Code Details

Product Code

EWL

Product Code Name

Prosthesis, Laryngeal (Taub)

Device Record Status

Public Device Record Key

a11933cf-f398-4db2-ac5b-53337263e36a

Public Version Date

June 19, 2020

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