FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022469
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Fluoro Extender
Device description
Fluoro Extender
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IXRTable, Radiographic, Tilting
IZZTable, Radiographic, Non-Tilting, Powered
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022469008174630224698174630224690817463022469

GMDN Terms#

Term, Definition table
TermDefinition
Radiological arm/leg positionerA device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

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
00817463027242Oakworks MedicalProcedure Chair Prone Face Rest System2023-12-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
07350006950070Sonesta P3Sonesta Medical ABMMZ2025-09-30
07350006950087Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950094Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950117Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950124Sonesta P3Sonesta Medical ABMMZ2025-09-30
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
S062110000ElevatorMaxPausch, L.L.C.IZZ2024-04-24
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00817463026405Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026412Oakworks Medical OAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
05999116100054PHOENIX 2CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2023-08-15
00817463026184Oakworks MedicalOAKWORKS, INC.IXR2023-07-17