Provox®2 - Provox2 is an indwelling, low resistance voice - Atos Medical AB

Duns Number:355470923

Device Description: Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration a Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.

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More Product Details

Catalog Number

7216

Brand Name

Provox®2

Version/Model Number

4.5 mm

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

K971244

Product Code Details

Product Code

EWL

Product Code Name

Prosthesis, Laryngeal (Taub)

Device Record Status

Public Device Record Key

0d9fed5f-ff3e-413c-8b16-db4befe12f61

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