Duns Number:355470923
Device Description: Provox FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the va Provox FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the valve closed during speech.
Catalog Number
-
Brand Name
Provox® FreeHands HME®
Version/Model Number
7710
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2016
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K022125
Product Code
EWL
Product Code Name
Prosthesis, Laryngeal (Taub)
Public Device Record Key
64e92b84-3c9a-4787-9676-6b01f00e6cb7
Public Version Date
August 23, 2018
Public Version Number
4
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 |