FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022476
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Carbon Fiber Arm Board
Device description
"Carbon Fiber Arm Board 1"" Pad"
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
IXQTable, Radiographic, Stationary Top
IZZTable, Radiographic, Non-Tilting, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022476008174630224768174630224760817463022476

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
00817463026412Oakworks Medical Adjustable T-Rail Clamp Accessory-12in2023-12-06
00817463026870Oakworks Medical PT300 Table2023-10-03
00817463026887Oakworks Medical PT300 Table2023-10-03
00817463025361Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115213Alta Indexing BarMEDTEC, INC.IXQ2026-05-06
00841439115152Upright Arm PositionerMEDTEC, INC.IXQ2026-01-08
00841439115145PronumbraMEDTEC, INC.IXQ2025-10-23
00841439114650PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114674PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114681PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114698PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114704PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114711PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114728PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114995PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115008PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115084ONEFitMEDTEC, INC.IXQ2025-09-12
00841439115121PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115138PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114732PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114749PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114770PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114787PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115015Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
00841439115022Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
00841439115039Posi Indexing BarMEDTEC, INC.IXQ2025-01-02
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
00841439114766Universal Couchtop™MEDTEC, INC.IXQ2024-10-18
00841439114759Rectangular ExtensionMEDTEC, INC.IXQ2024-10-01
B237OGSAPH100Diacor CT OverlayDiacor, Inc.IXQ2024-07-11
00841439114599Pro Posifix® Headrest AdapterMEDTEC, INC.IXQ2024-05-16
S062110000ElevatorMaxPausch, L.L.C.IZZ2024-04-24
00841439114513Mevion Rectangular BackrestMEDTEC, INC.IXQ2024-02-03