Duns Number:623527962
Device Description: Oral Device For The Treatment Of Obstructive Sleep Apnea.
Catalog Number
-
Brand Name
Herbst Telescopic Flex
Version/Model Number
H1001
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
K130558
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
2d1e3d1c-7c3f-439d-8a8d-df415f726113
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 14, 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. | 21 |
U | Unclassified | 1 |