Duns Number:007198742
Device Description: Septal Buttons are used to close nasal septal perforations and can be trimmed to the desig Septal Buttons are used to close nasal septal perforations and can be trimmed to the designated size The procedure can be done in the office using local anesthesia or in conjunction with some other intranasal surgery
Catalog Number
-
Brand Name
SEPTAL BUTTON SILICONE
Version/Model Number
890924
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K781574
Product Code
FZE
Product Code Name
Prosthesis, Nose, Internal
Public Device Record Key
e1431a05-496a-4f31-846d-def312ebffbd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |