Duns Number:109903521
Device Description: MEDIENT MIDDLE TURBINATE IMPLANT 4-PACK
Catalog Number
602-00210
Brand Name
ENT Sinus
Version/Model Number
602-00210
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
K130354,K130354
Product Code
LYA
Product Code Name
SPLINT, INTRANASAL SEPTAL
Public Device Record Key
a961e15a-ba9b-4a78-a69a-4e981a5fe0cd
Public Version Date
December 21, 2020
Public Version Number
6
DI Record Publish Date
August 30, 2015
Package DI Number
20817470009761
Quantity per Package
4
Contains DI Package
00817470009767
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |