Duns Number:529128624
Device Description: The Moses appliance is intended for use on adult patients 18 years of age and older as an The Moses appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and /or alleviation of snoring and mild to moderate obstrctive sleep apnea.
Catalog Number
-
Brand Name
The Moses appliance
Version/Model Number
001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
c3123a1a-fc7e-41ea-a48a-c9c700e44a29
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 24, 2018
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 |