Niti-S Colonic Comfort Stent

FDA UDI

Class II (US FDA UDI)

by Taewoong Medical

Identity

Trade Name: Niti-S Colonic Comfort Stent FDA UDI
Generic Name: Bare-metal colonic stent FDA UDI
Device Name: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent. FDA UDI
Model / Reference: CDT2206N-22 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809909414367 FDA UDI
FDA Product Code: MQR FDA UDI
GMDN Term: Bare-metal colonic stent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3610 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Stent Diameter — 22 Millimeter FDA UDI
Catheter Working Length — 220 Centimeter FDA UDI
Crossing Profile — 10 French FDA UDI
Stent Length — 60 Millimeter FDA UDI

Category: Bare-metal colonic stent

Niti-S Colonic Comfort Stent by Taewoong Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal colonic stent.

WALLSTENT™ Enteral Endoprosthesis — Boston Scientific · Class II
HANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd. · Class II
WallFlex™ Colonic — Boston Scientific · Class II
WallFlex™ Colonic — Boston Scientific · Class II
WallFlex™ Colonic — Boston Scientific · Class II
WallFlex™ Colonic — Boston Scientific · Class II
HANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd. · Class II
HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Taewoong Medical

Sources (1)

FDA UDI 2fe7255d-a886-4091-ae31-be585af893f3 36 fields · synced Jun 1, 2026