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HANAROSTENT® Trachea/Bronchium(CCC)

FDA UDI

Class II (US FDA UDI)

by M.I.Tech Co., Ltd.

Identity

Trade Name
HANAROSTENT® Trachea/Bronchium(CCC) FDA UDI
Generic Name
Polymer-metal tracheal/bronchial stent FDA UDI
Device Name
Full Covered metallic tracheal stent FDA UDI
Model / Reference
TCS-12-060-090 FDA UDI
Description
Full Covered metallic tracheal stent FDA UDI

Identifiers

Primary DI / UDI-DI
08806367080066 FDA UDI
510(k) Number
K201342 FDA UDI
FDA Product Code
JCT FDA UDI
GMDN Term
Polymer-metal tracheal/bronchial stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3720 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 Conditional FDA UDI

Dimensions & Sizes

Size
Stent Diameter — 12 Millimeter FDA UDI
Stent Length — 60 Millimeter FDA UDI

Category: Polymer-metal tracheal/bronchial stent

HANAROSTENT® Trachea/Bronchium(CCC) by M.I.Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer-metal tracheal/bronchial stent.

Cleared under the same submission

K201342 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 7268b58f-84f2-4055-9a75-a7e2f340f3d3 37 fields · synced Jun 7, 2026