Endoscopic Sinus Surgery Kit CSK-4

GUDID 09400998100040

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 syringe The 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

Intranasal splint, biodegradable

• Primary Device ID: 09400998100040
• NIH Device Record Key: a77df7f3-7230-4872-9f0c-1b016c7e8bba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoscopic Sinus Surgery Kit
• Version Model Number: CSK-4
• Catalog Number: CSK-4
• Company DUNS: 594867708
• Company Name: CHITOGEL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09400998100040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172179

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-12-21
• Device Publish Date: 2019-02-18