FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463027242
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Procedure Chair Prone Face Rest System
Device description
Face rest cushion and platform designed for use with Oakworks Procedure Chairs: intended for use by healthcare professional
Published
2023-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00817463027242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463027242008174630272428174630272420817463027242

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Regulatory Flags#

DUNS number
130256837
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817463026719Oakworks MedicalPT100 Table2023-08-08
00817463026436Oakworks MedicalUrology Table Drape2023-12-06
00817463027129Oakworks MedicalDetachable Arm Board2023-12-06
00817463027136Oakworks MedicalPowerline Table Extender2023-12-06
00817463027143Oakworks MedicalPowerline Table Extender2023-12-06
00817463027174Oakworks MedicalPatient Strap - Ultrasound EA2023-12-06
00817463026870Oakworks MedicalPT300 Table2023-10-03
00817463026887Oakworks MedicalPT300 Table2023-10-03
00817463025378Oakworks MedicalUltrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks MedicalUltrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks MedicalUltrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks MedicalUltrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks MedicalUltrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks MedicalPT300 Table2023-10-02
00817463026931Oakworks MedicalPT400 Table2023-10-02
00817463026948Oakworks MedicalPT400 Table2023-10-02
00817463026955Oakworks MedicalPT400 Table2023-10-02
00817463026979Oakworks MedicalPT400M Table2023-10-02
00817463025484Oakworks MedicalUltrasound EA General 3 Section Table or Multi-Spe2023-09-29
00817463025491Oakworks MedicalUltrasound EA General 3 Section Table or Women's (2023-09-29

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
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00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10