ErgoSupport Step Stool, non-sterile

FDA UDI

Class I (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: ErgoSupport Step Stool, non-sterile FDA UDI
Generic Name: Operating room stool FDA UDI
Device Name: Intended to act as an ergonomic product that reduces fatigue of nurses and surgeons experienced from long hours of standing in one location. FDA UDI
Model / Reference: ST-001 FDA UDI
Description: Intended to act as an ergonomic product that reduces fatigue of nurses and surgeons experienced from long hours of standing in one location. FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113207411 FDA UDI
FDA Product Code: FZM FDA UDI
GMDN Term: Operating room stool 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room stool

ErgoSupport Step Stool, non-sterile by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Aspen Surgical Products, Inc.

Sources (1)

FDA UDI 10ab160b-d70c-4a44-8892-44c393950f09 34 fields · synced Jun 9, 2026