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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
WALLFLEX BILIARY RX COVERED 10X80 FDA UDI
Model / Reference
M00570540 FDA UDI
Description
WALLFLEX BILIARY RX COVERED 10X80 FDA UDI

Identifiers

Primary DI / UDI-DI
08714729764922 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Polymer-metal biliary stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI e6c3aac0-db26-4593-a750-47f213673977 34 fields · synced Jun 8, 2026