Niti-S Colonic Comfort Stent

Basic Information

• Brand Name: Niti-S Colonic Comfort Stent
• Primary DI: 08809909414428
• Version / Model: CDT2410N-22
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• Labeler DUNS: 689484322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 457a590c-a749-4c75-9e45-6dbde1b62737

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809909414428	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K223067	000

Device Sizes

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius