FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463025361
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Ultrasound EA General 2 Section Table
Device description
30in width 2-section table: intended for use by a healthcare professional in a medical environment: 230VAC
Published
2023-10-02
Public version status
Update
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
00817463025361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463025361008174630253618174630253610817463025361

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
130256837
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817463026412Oakworks Medical Adjustable T-Rail Clamp Accessory-12in2023-12-06
00817463026870Oakworks Medical PT300 Table2023-10-03
00817463026887Oakworks Medical PT300 Table2023-10-03
00817463025378Oakworks Medical Ultrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks Medical Ultrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks Medical Ultrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks Medical Ultrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks Medical PT300 Table2023-10-02
00817463026931Oakworks Medical PT400 Table2023-10-02
00817463026948Oakworks Medical PT400 Table2023-10-02
00817463026955Oakworks Medical PT400 Table2023-10-02
00817463026979Oakworks Medical PT400M Table2023-10-02
00817463025484Oakworks Medical Ultrasound EA General 3 Section Table or Multi-Spe2023-09-29
00817463025491Oakworks Medical Ultrasound EA General 3 Section Table or Women's (2023-09-29
00817463025507Oakworks Medical Ultrasound EA General 3 Section Table2023-09-28
00817463025569Oakworks Medical Ultrasound EA Vascular Table2023-09-28
00817463025576Oakworks Medical EA Vascular Table with Fowler (V2 Model)2023-09-28
00817463025606Oakworks Medical Ultrasound EA Vascular Table2023-09-28
00817463026634Oakworks Medical Powerline Backrest Top Exam Table2023-08-21

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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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