FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022513
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Carbon Fiber Arm Board
Device description
"Carbon Fiber Arm Board with 4"" pad"
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022513008174630225138174630225130817463022513

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
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
00841439115213Alta Indexing BarMEDTEC, INC.IXQ2026-05-06
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
00841439115152Upright Arm PositionerMEDTEC, INC.IXQ2026-01-08
00841439115145PronumbraMEDTEC, INC.IXQ2025-10-23
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
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
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
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01