FDA.reportPublic FDA data

ST-4000

Primary DI
08809832900050
Brand
ST-4000
Company
SHINYOUNG FOR M CO.,LTD.
Model
ST-4000_V1
Published
2023-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809832900050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809832900050088098329000508809832900050

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689883945
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809832900302SST-4100SV12026-05-27
08809832900258SD-3100SD-3100_V12024-04-04
08809832900012ST-1000ST-1000_V22023-11-20
08809832900074LSS-2000LSS-2000_V22023-11-20
08809832900098SST-3100SST-3100_V12023-11-20
08809832900104SST-3001SST-3001_V12023-11-20
08809832900111SU-2100SU-2100_V12023-11-20
08809832900128SU-4500SU-4500_V22023-11-20
08809832900159LSS-1000LSS-1000_V12023-11-20
08809832900166SU-2000SU-2000_V12023-11-20
08809832900173SD-3500SD-3500_V12023-11-20
08809832900180SU-4000SU-4000_V52023-11-20
08809832900197SD-6000SD-6000_V12023-11-20
08809832900227SS-2100SS-2100_V12023-11-20
08809832900234SS-2100SS-2100_V22023-11-20
08809832900241SD-6000SD-6000_V22023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
00728564057000Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
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00728564058014Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564060000Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564065005Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564065012Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564068006Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564068013Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564157007Flex Plus Access Exam TableThe Brewer Company LLCLGX2025-11-10
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00728564165002Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564165019Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564168003Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564168010Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10