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BONASTENT® Tracheal/Bronchial

FDA UDI

Class II (US FDA UDI)

by Sewoon Medical Co., Ltd.

Identity

Trade Name
BONASTENT® Tracheal/Bronchial FDA UDI
Generic Name
Polymer-metal tracheal/bronchial stent FDA UDI
Model / Reference
BTB-100609 FDA UDI

Identifiers

Primary DI / UDI-DI
08806369468183 FDA UDI
510(k) Number
K140472 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

Category: Polymer-metal tracheal/bronchial stent

BONASTENT® Tracheal/Bronchial by Sewoon Medical 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

K140472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sewoon Medical Co., Ltd.

Sources (1)

  • FDA UDI de9f98ae-fd4a-40f6-90a0-f0051999628f 34 fields · synced Jun 8, 2026