Identity
- Trade Name
- Setmark FDA UDI
- Generic Name
- Footstool FDA UDI
- Device Name
- Footstool stainless steel,30"W x 8"H x 12"D - black matting FDA UDI
- Model / Reference
- SS-103 FDA UDI
- Description
- Footstool stainless steel,30"W x 8"H x 12"D - black matting FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854204008177 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
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.
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- 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 473271b7-96f1-474d-9f89-96ae409edcf6 33 fields · synced May 30, 2026