Duns Number:940968808
Device Description: Implants and delivery tools for hyoid and tongue suspension.
Catalog Number
-
Brand Name
Encore System
Version/Model Number
FG0002
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133680
Product Code
ORY
Product Code Name
Prelude Tongue Suspension System
Public Device Record Key
5ba93e0f-9df4-4142-a84c-cd29ee791fee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 07, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |