Duns Number:355470923
Device Description: Provox Luna Adhesive is a skin-friendly, single use adhesive that provides attachment for Provox Luna Adhesive is a skin-friendly, single use adhesive that provides attachment for the Provox Luna HME for night-time use after totallaryngectomy.
Catalog Number
8014
Brand Name
Provox Luna
Version/Model Number
Adhesive
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
f3c0edc5-7681-414b-a759-75b7345ef345
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 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 |