AccessGUDID - DEVICE: Niti-S Colonic Comfort Stent (08809909414428)

GUDID

Device Identifier (DI) Information

Brand Name: Niti-S Colonic Comfort Stent
Version or Model: CDT2410N-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TAEWOONGMEDICAL.CO.,LTD

Primary DI Number: 08809909414428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689484322 *Terms of Use

Device Description: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
37847	Bare-metal colonic stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. It is typically inserted and advanced to the site of implantation with a dedicated catheter, or other instrument, where it self-expands upon release. It is made of metal [e.g., stainless steel or metal alloy such as nickel-titanium alloy (Nitinol)] in a tubular mesh configuration, and is available in various sizes. It will typically be used to relieve large bowel obstruction prior to colectomy, or in patients having high operative risk and/or advanced disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQR	Stent, Colonic, Metallic, Expandable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223067	000
K250663	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
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Working Length: 220 Centimeter
Crossing Profile: 10 French
Stent Diameter: 24 Millimeter
Stent Length: 100 Millimeter

Device Record Status

Public Device Record Key: 457a590c-a749-4c75-9e45-6dbde1b62737
Public Version Date: November 21, 2025
Public Version Number: 3
DI Record Publish Date: June 20, 2023