FDA.reportPublic FDA data

Setmark Inc.

Primary DI
00854204008450
Brand
Setmark Inc.
Company
SETMARK INC.
Model
ST-103
Device description
Aluminum Overbed Table
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
HRKTable, Instrument, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRKTable, Instrument, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854204008450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854204008450008542040084508542040084500854204008450

GMDN Terms#

Term, Definition table
TermDefinition
Overbed tableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080798558
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854204008146SetmarkSS-1002024-10-15
00854204008153SetmarkSS-1012024-10-15
00854204008160SetmarkSS-1022024-10-15
00854204008177SetmarkSS-1032024-10-15
00854204008184SetmarkSS-1042024-10-15
00854204008191SetmarkSS-1052024-10-15
00854204008306SetmarkDC-1002024-10-15
00854204008313SetmarkDC-1012024-10-15
00854204008320SetmarkDC-1022024-10-15
00854204008337SetmarkDC-1032024-10-15
00854204008344SetmarkDC-1042024-10-15
00854204008603Setmark Inc.DC-1082024-04-21
00865388000482Setmark IncorporatedWA-1752018-01-31
00865388000499Setmark IncorporatedWA-1762018-01-31
00854204008030Setmark IncorporatedTR-1352018-01-31
00854204008597Setmark Inc.NF300/6277102020-03-23
00854204008047Setmark IncorporatedTR-1362018-01-31
00854204008054Setmark IncorporatedWC-1012018-01-31
00854204008061Setmark IncorporatedWC-1022018-01-31
00854204008078Setmark IncorporatedWC-1042018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057027233726UFSK-OSYS Instrument tableUFSK-International OSYS GmbHHRK2026-03-02
10810030863332NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863349NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863356NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863363NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863370NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863387NAMID CENTRAL MEDICAL CORP.HRK2022-04-01
10810030863271NAMID CENTRAL MEDICAL CORP.HRK2021-09-20
10810030863288NAMID CENTRAL MEDICAL CORP.HRK2021-09-20
10810030863295NAMID CENTRAL MEDICAL CORP.HRK2021-09-20
10810030863301NAMID CENTRAL MEDICAL CORP.HRK2021-09-20
10810030862908NAMID CENTRAL MEDICAL CORP.HRK2020-12-15
10810030862915NAMID CENTRAL MEDICAL CORP.HRK2020-12-15
10810030862922NAMID CENTRAL MEDICAL CORP.HRK2020-12-15
10810030862939NAMID CENTRAL MEDICAL CORP.HRK2020-12-15
10810030862946NAMID CENTRAL MEDICAL CORP.HRK2020-12-15
10810030861772NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861789NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861796NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861802NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861819NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861826NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861833NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861840NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861857NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861864NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861871NAMID CENTRAL MEDICAL CORP.HRK2020-11-16
10810030861680NAMID CENTRAL MEDICAL CORP.HRK2020-10-31
10810030861697NAMID CENTRAL MEDICAL CORP.HRK2020-10-31
10810030861703NAMID CENTRAL MEDICAL CORP.HRK2020-10-31