Duns Number:355470923
Device Description: Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling t Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Catalog Number
7111
Brand Name
Provox® NID™
Version/Model Number
20 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043138
Product Code
EWL
Product Code Name
Prosthesis, Laryngeal (Taub)
Public Device Record Key
018b2323-4538-44a5-80e9-97dc4281f7ba
Public Version Date
July 06, 2018
Public Version Number
3
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 |