Duns Number:024222105
Device Description: Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.
Catalog Number
08-015-00-V04
Brand Name
Renú Gel
Version/Model Number
08-015-00-V04
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
-
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
-
Product Code
MIX
Product Code Name
System, Vocal Cord Medialization
Public Device Record Key
a7b88b09-bb30-461b-8f50-ea23303f8cd1
Public Version Date
November 07, 2019
Public Version Number
1
DI Record Publish Date
October 30, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |