Duns Number:551746187
Device Description: The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic appliance
Catalog Number
-
Brand Name
Elastic Mandibular Advancement (EMA) appliance
Version/Model Number
003
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
c1a5442b-2a11-4e7e-bbae-3180426b4fb0
Public Version Date
November 29, 2019
Public Version Number
1
DI Record Publish Date
November 21, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |