FDA.reportPublic FDA data

CHITOGEL LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146537903014653790CHITOGEL LIMITED1N2026-01-0168 Ward St Wallaceville Upper Hutt Wellington NZ 5018

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2198921350510772K172179Chitogel Endoscopic Sinus Surgery KitLYA2017-10-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYA12017-10-17

PMN#

GUDID#

Endoscopic Sinus Surgery Kit - 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.

CHITOGEL LIMITED

2019-02-18