Duns Number:600613055
Device Description: The Composite Removable Sinus Stent is intended for use in adult patients following ethmoi The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, tomaintain patency and reduce the need of post-operative intervention or revision surgery. The composite stent isintended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steadysupport of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction byadhesions. The stent can be removed at any time within 28 days by cooling and self-crimping
Catalog Number
-
Brand Name
ArchSinus Stent System
Version/Model Number
712-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K170913
Product Code
LYA
Product Code Name
Splint, Intranasal Septal
Public Device Record Key
f7d474e8-6cc1-4557-b468-f1a00d1ae2c3
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
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 | 1 |