Setmark Inc.

Basic Information

• Brand Name: Setmark Inc.
• Primary DI: 00854204008450
• Version / Model: ST-103
• Company Name: SETMARK INC.
• Labeler DUNS: 080798558
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-27
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: 466e9b56-a28b-4626-957a-5171c31f5148

Device Description

Aluminum Overbed Table

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRK	Table, Instrument, Manual, Ophthalmic	Ophthalmic	886.4855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35395	Overbed table	A table designed to be moved directly over the bed of a patient/occupant to provide them with a surface to eat, read, or write while in bed. It is typically constructed as a C-shaped metal framework with a table top surface, on which objects are placed, and small Castor wheels to provide the mobility for moving it over the bed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854204008450	GS1