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…
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.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Endoscopic Sinus Surgery Kit | Listed by | Chitogel Limited, New Zealand |
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K172179 |
| Record published | 2019-02-18 |
| Record revised | 2020-12-21 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.