CHITOGEL LIMITED

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Splint, Intranasal Septal (LYA) (1)

Premarket Exempt

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Endoscopic Sinus Surgery Kit - 09400998100040 Catalog Number : CSK-4

Device Description : The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: 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.

Device Class : 1

Duns Number: 594867708

Premarket Exempt : No

Product Code : LYA

Prescription Use : Yes

Device Count : 1

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