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One

FDA UDI

Class I (US FDA UDI)

by WillowWood Global LLC

Identity

Trade Name
One FDA UDI
Generic Name
External lower-limb prosthesis suspensory component, powered FDA UDI
Device Name
WillowWood One TF System, Distal Mount LLVS 2 with One Liner Kit, XL FDA UDI
Model / Reference
ONE-TF-DISTAL-4 FDA UDI
Description
WillowWood One TF System, Distal Mount LLVS 2 with One Liner Kit, XL FDA UDI

Identifiers

Catalog Number
ONE-TF-DISTAL-4 FDA UDI
Primary DI / UDI-DI
00194711300945 FDA UDI
FDA Product Code
ISP FDA UDI
IPM FDA UDI
ISS FDA UDI
GMDN Term
External lower-limb prosthesis suspensory component, powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 FDA UDI
890.3025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External limb prosthesis socket linerExternal lower-limb prosthesis suspensory component, poweredExternal lower-limb prosthesis socket, non-customizedExternal lower-limb prosthesis socket, custom-made

One by WillowWood Global LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External lower-limb prosthesis socket, non-customized.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WillowWood Global LLC

Sources (1)

  • FDA UDI f2c7e1a1-afe6-47da-adcb-fd152528a858 35 fields · synced May 30, 2026