Endoscopic Sinus Surgery Kit

Primary DI
09400998100040
Brand
Endoscopic Sinus Surgery Kit
Company
CHITOGEL LIMITED
Model
CSK-4
Catalog number
CSK-4
Device 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 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.
Published
2019-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172179000Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.2017-10-17LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09400998100040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09400998100040094009981000409400998100040

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, biodegradableA bioabsorbable device intended to be placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made of non-animal source material which chemically degrades after about 3 – 4 weeks and is absorbed via natural body processes, or it may be removed at the discretion of the physician. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
594867708
Device count
1
Lot or batch
true
Expiration date on label
true

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