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Chitogel Endoscopic Sinus Surgery Kit

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref NAModel CSK-4

by Chitogel Limited

Identity

Trade Name
Chitogel Endoscopic Sinus Surgery Kit EUDAMED
Endoscopic Sinus Surgery Kit FDA UDI
Generic Name
Intranasal splint, biodegradable FDA UDI
Device Name
Chitogel Endoscopic Sinus Surgery Kit EUDAMED
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. FDA UDI
Model / Reference
CSK-4 EUDAMEDFDA UDI
NA EUDAMED
Description
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. FDA UDI

Identifiers

Catalog Number
CSK-4 FDA UDI
Primary DI / UDI-DI
09400998100040 EUDAMEDFDA UDI
Basic UDI-DI
B-09400998100040 EUDAMED
510(k) Number
K172179 FDA UDI
FDA Product Code
LYA FDA UDI
EMDN Code
Q0399 ENT DEVICES - OTHER EUDAMED
GMDN Term
Intranasal splint, biodegradable FDA UDI

Classification

Device Class
Class III EUDAMED
Class I FDA UDI
Regulation Number
874.4780 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Chitogel Endoscopic Sinus Surgery Kit by Chitogel Limited — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Chitogel Limited
EUDAMED SRN
NZ-MF-000021666
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED 039d2d16-6b20-4471-965a-ca04e0913729 61 fields · synced Aug 3, 2026
  • FDA UDI a77df7f3-7230-4872-9f0c-1b016c7e8bba 35 fields · synced May 30, 2026
  • FDA 510(k) K172179 1 fields · synced May 18, 2026