FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463021363
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
"Extension - Lateral 5 x 24"""
Device description
"Extension - Lateral 5 x 24"""
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463021363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463021363008174630213638174630213630817463021363

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
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
00841439115039Posi Indexing BarMEDTEC, INC.IXQ2025-01-02
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
00841439114513Mevion Rectangular BackrestMEDTEC, INC.IXQ2024-02-03
00841439114544Universal Couchtop™MEDTEC, INC.IXQ2024-01-22
00841439114551Universal Couchtop™MEDTEC, INC.IXQ2024-01-22
00841439113578Rectangular BackrestMEDTEC, INC.IXQ2023-06-10