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Tracheal Stent system (OTW)

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Tracheal Stent system (OTW) FDA UDI
Generic Name
Polymer-metal tracheal/bronchial stent FDA UDI
Device Name
Double Spherical10×50,Partially Covered,4.0×650 FDA UDI
Model / Reference
NST02-332-10.050 FDA UDI
Description
Double Spherical10×50,Partially Covered,4.0×650 FDA UDI

Identifiers

Primary DI / UDI-DI
06932503580748 FDA UDI
510(k) Number
K202204 FDA UDI
FDA Product Code
NST FDA UDI
GMDN Term
Polymer-metal tracheal/bronchial stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Stent Diameter — 10 Millimeter FDA UDI
Stent Length — 50 Millimeter FDA UDI

Category: Polymer-metal tracheal/bronchial stent

Tracheal Stent system (OTW) by Micro-Tech (Nanjing) 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

K202204 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI 3d2f4e41-9ade-4f5f-83b0-b11df71d6d55 36 fields · synced May 30, 2026