AccessGUDID - DEVICE: Endoscopic Sinus Surgery Kit (09400998100040)

GUDID

Device Identifier (DI) Information

Brand Name: Endoscopic Sinus Surgery Kit
Version or Model: CSK-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSK-4
Company Name: CHITOGEL LIMITED

Primary DI Number: 09400998100040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 594867708 *Terms of Use

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 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41493	Intranasal splint, biodegradable	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172179	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a77df7f3-7230-4872-9f0c-1b016c7e8bba
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: February 18, 2019