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Ultraflex™ Tracheobronchial

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Ultraflex™ Tracheobronchial FDA UDI
Generic Name
Bare-metal tracheal/bronchial stent FDA UDI
Device Name
Proximal Release Stent System FDA UDI
Model / Reference
M00576420 FDA UDI
Description
Proximal Release Stent System FDA UDI

Identifiers

Primary DI / UDI-DI
08714729837787 FDA UDI
FDA Product Code
JCT FDA UDI
GMDN Term
Bare-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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bare-metal tracheal/bronchial stent

Ultraflex™ Tracheobronchial by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal tracheal/bronchial stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI c3c7a5dc-ebf5-4fa5-bcd2-a0f24b5a7049 34 fields · synced Jun 8, 2026