Duns Number:203417571
Device Description: The Good Morning Snore Solution - An intraoral device for the reduction of snoring for adu The Good Morning Snore Solution - An intraoral device for the reduction of snoring for adults at least 18 years old.
Catalog Number
-
Brand Name
Good Morning Snore Solution
Version/Model Number
1
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
-
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
K193239
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
d2f10636-3f54-402b-8df8-34cbb59a5352
Public Version Date
January 21, 2020
Public Version Number
5
DI Record Publish Date
December 05, 2016
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. | 1 |