Duns Number:059636679
Device Description: Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep ap Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea.
Catalog Number
-
Brand Name
Blue + Hard/Soft
Version/Model Number
SBP020US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K111207
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
7d2c9252-f71e-45a7-96f8-f94c7eb4f8b0
Public Version Date
February 17, 2020
Public Version Number
5
DI Record Publish Date
June 15, 2017
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. | 28 |