FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463027198
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
100 Series Face Cushion
Device description
100 Series Face Cushion
Published
2023-12-06
Public version status
Update
Distribution status
Not 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
00817463027198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463027198008174630271988174630271980817463027198

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

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
00817463026719Oakworks MedicalPT100 Table2023-08-08
00817463026405Oakworks MedicalAdjustable T-Rail Clamp Accessory-6in2023-12-06
00817463026412Oakworks MedicalAdjustable T-Rail Clamp Accessory-12in2023-12-06
00817463027143Oakworks MedicalPowerline Table Extender2023-12-06
00817463026870Oakworks MedicalPT300 Table2023-10-03
00817463025408Oakworks MedicalUltrasound EA General 2 Section Table2023-10-02
00817463026894Oakworks MedicalPT300 Table2023-10-02
00817463026931Oakworks MedicalPT400 Table2023-10-02
00817463026955Oakworks MedicalPT400 Table2023-10-02
00817463025507Oakworks MedicalUltrasound EA General 3 Section Table2023-09-28
00817463025606Oakworks MedicalUltrasound EA Vascular Table2023-09-28
00817463026634Oakworks MedicalPowerline Backrest Top Exam Table2023-08-21
00817463025453Oakworks MedicalUltrasound EA General 3 Section Table2023-08-19
00817463026665Oakworks MedicalPT100 Table2023-08-19
00817463026689Oakworks MedicalPT100 Table2023-08-19
00817463026726Oakworks MedicalPT150 Table2023-08-19
00817463026740Oakworks MedicalPT150 Table2023-08-19
00817463026788Oakworks MedicalPT250 Table2023-08-19
00817463026801Oakworks MedicalPT250 Table2023-08-19
00817463026849Oakworks MedicalPT300 Table2023-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544010CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544027CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544034CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544041CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544058CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
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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00728564060000Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
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00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10