Setmark

FDA UDI

Class I (US FDA UDI)

by Setmark Inc.

Identity

Trade Name: Setmark FDA UDI
Generic Name: Footstool FDA UDI
Device Name: Double Footstool. Stainless steel- 16" W x 16" L x 25" depth - black matting FDA UDI
Model / Reference: SS-104 FDA UDI
Description: Double Footstool. Stainless steel- 16" W x 16" L x 25" depth - black matting FDA UDI

Identifiers

Primary DI / UDI-DI: 00854204008184 FDA UDI
FDA Product Code: FZM FDA UDI
GMDN Term: Footstool FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Footstool

Setmark by Setmark Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Footstool.

Assembly Required Distributors — Assembly Required Distributors Inc · Class I
Stackable Foot Stool Orange mat — Batrik Medical Manufacturing Inc · Class I
Imperial Stackable Step stool without mat — Imperial Surgical Ltd · Class I
LUMEX — GF Health Products, Inc · Class I
Assembly Required Distributors — Assembly Required Distributors Inc · Class I
Assembly Required Distributors — Assembly Required Distributors Inc · Class I
Imperial SS Stackable Foot Stool — Imperial Surgical Ltd · Class I
Imperial Single Step Footstool — Imperial Surgical Ltd · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Setmark Inc.

Sources (1)

FDA UDI f65659bc-81ab-4e5d-9006-aa10d2348be8 33 fields · synced Jun 8, 2026