Duns Number:622812592
Device Description: A device that is implanted to occlude a perforation in the nasal septum. It typically cons A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.
Catalog Number
20-10400S
Brand Name
Invotec Nasal Septal Button
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K901366
Product Code
LFB
Product Code Name
Button, Nasal Septal
Public Device Record Key
053f02f1-7cce-4002-a30a-2706e911b198
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 03, 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. | 69 |
| U | Unclassified | 2 |