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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

7221

Brand Name

Provox®2

Version/Model Number

12.5 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

64ebf3c7-0309-4396-911f-ba0559463b73

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