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WallFlex™ Biliary Transhepatic

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
WallFlex™ Biliary Transhepatic FDA UDI
Generic Name
Nappy changing table, portable FDA UDI
Device Name
Stent System FDA UDI
Model / Reference
M00574630 FDA UDI
Description
Stent System FDA UDI

Identifiers

Primary DI / UDI-DI
08714729799412 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Nappy changing table, portable 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

No

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: Nappy changing table, portable

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

Similar devices

Also classified as Nappy changing table, portable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 8cd9b55b-9399-4d3d-b2d5-91ed6395a5eb 34 fields · synced May 30, 2026