Duns Number:028147846
Device Description: Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat voca Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.
Catalog Number
-
Brand Name
Prolaryn Gel Injectable Implant
Version/Model Number
8602M0K5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
For Single-Use
Yes
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
K060815
Product Code
MIX
Product Code Name
System, Vocal Cord Medialization
Public Device Record Key
f6151d8a-dc07-4c6c-b00c-988b3077f244
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 28, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 8 |