Duns Number:016649253
Device Description: The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. Itconsists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep.
Catalog Number
-
Brand Name
mmRNA appliance
Version/Model Number
3014680794
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210203
Product Code
LQZ
Product Code Name
Device, Jaw Repositioning
Public Device Record Key
883827ef-fb0d-492d-8a88-0fc5c8548b72
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |