Duns Number:594867708
Device Description: The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed v The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed vial containing 350mg Dextran Aldehyde Powder- Sealed vial containing 12ml Sodium Phosphate Buffer Solution- Sealed vial containing 12ml Chitosan Succinamide Solution- Fluid dispensing connector- Two (2) mixing cannulae- Malleable cannulae- Two (2) 20ml sterile luer lock syringeThe Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the two 20 ml sterile syringe and cannulae provided. The pre-measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.All components are provide sterile and are for single use only.
Catalog Number
CSK-4
Brand Name
Endoscopic Sinus Surgery Kit
Version/Model Number
CSK-4
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
K172179
Product Code
LYA
Product Code Name
Splint, Intranasal Septal
Public Device Record Key
a77df7f3-7230-4872-9f0c-1b016c7e8bba
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
February 18, 2019
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 |