← Back to catalogue

WallFlex™ Duodenal

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
WallFlex™ Duodenal FDA UDI
Generic Name
Bare-metal duodenal stent FDA UDI
Device Name
Stent System with Anchor Lock Delivery System FDA UDI
Model / Reference
M00555880 FDA UDI
Description
Stent System with Anchor Lock Delivery System FDA UDI

Identifiers

Primary DI / UDI-DI
08714729902515 FDA UDI
510(k) Number
K200257 FDA UDI
FDA Product Code
MUM FDA UDI
GMDN Term
Bare-metal duodenal stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3610 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

Dimensions & Sizes

Size
Stent Length — 120 Millimeter FDA UDI
Stent Diameter — 22 Millimeter FDA UDI

Category: Bare-metal duodenal stent

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

Similar devices

Also classified as Bare-metal duodenal stent.

Cleared under the same submission

K200257 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 20ad6685-33c2-4214-af36-633347b38051 35 fields · synced May 30, 2026