Niti-S Duodenal Comfort Stent

Basic Information

• Brand Name: Niti-S Duodenal Comfort Stent
• Primary DI: 08809909414329
• Version / Model: PDT2206N-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: 671fd2df-b667-416e-ad66-f60d6cb91f24

Device Description

The Niti-S Duodenal 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
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32640	Bare-metal duodenal stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809909414329	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
Stent Diameter	22	Millimeter
Stent Length	60	Millimeter
Catheter Working Length	220	Centimeter
Crossing Profile	10	French

Storage Conditions

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