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HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)

FDA UDI

Class II (US FDA UDI)

by M.I.Tech Co., Ltd.

Identity

Trade Name
HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) FDA UDI
Generic Name
Bare-metal duodenal stent FDA UDI
Device Name
Un-covered self-expanding nitinol Duodenum stent FDA UDI
Model / Reference
DNJF-22-090-140 FDA UDI
Description
Un-covered self-expanding nitinol Duodenum stent FDA UDI

Identifiers

Primary DI / UDI-DI
08806367076663 FDA UDI
510(k) Number
K180180 FDA UDI
FDA Product Code
MUM FDA UDI
GMDN Term
Bare-metal duodenal 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 1400 Millimeter FDA UDI
Stent Length — 90 Millimeter FDA UDI
Stent Diameter — 22 Millimeter FDA UDI

Category: Bare-metal duodenal stent

HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) by M.I.Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal duodenal stent.

Cleared under the same submission

K180180 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.I.Tech Co., Ltd.

Sources (1)

  • FDA UDI ef155eed-8fae-4670-ae80-0926f27bb396 37 fields · synced May 30, 2026