Duns Number:355470923
Device Description: Provox LaryButton is a self-retaining holder for devices in the Provox HME system intended Provox LaryButton is a self-retaining holder for devices in the Provox HME system intended for vocal and pulmonary rehabilitation after total laryngectomy.For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox LaryButton is intended for single patient use.
Catalog Number
7673
Brand Name
Provox LaryButton
Version/Model Number
16/8
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KAC
Product Code Name
Tube, Laryngectomy
Public Device Record Key
d0146017-74ca-4c64-9f49-0870c8fedc71
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 08, 2022
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 |