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WallFlex Biliary

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
WallFlex Biliary FDA UDI
Generic Name
Polymer-metal biliary stent, non-bioabsorbable FDA UDI
Device Name
Stent System RMV FDA UDI
Model / Reference
M00570350 FDA UDI
Description
Stent System RMV FDA UDI

Identifiers

Primary DI / UDI-DI
08714729953166 FDA UDI
510(k) Number
DEN150040 FDA UDI
FDA Product Code
PNB FDA UDI
GMDN Term
Polymer-metal biliary stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5011 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: Polymer-metal biliary stent, non-bioabsorbable

WallFlex Biliary by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer-metal biliary stent, non-bioabsorbable.

Cleared under the same submission

DEN150040 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI d92aadb4-ffbd-405c-a14b-fa7d59982b07 35 fields · synced May 30, 2026