FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463026252
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
CFPM302 RT Table
Device description
Three movement radiographic table intended for use with C-Arm imaging systems; ideally suited for pain management imaging and therapeutic procedures; intended for use by a healthcare professional: 230VAC
Published
2023-07-17
Public version status
Update
Distribution status
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
IXRTable, Radiographic, Tilting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463026252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463026252008174630262528174630262520817463026252

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table, poweredA powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

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
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
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
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 MedicalOAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026184Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026214Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026221Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026238Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026276Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026306Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026313Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026320Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463025941Oakworks MedicalOAKWORKS, INC.IXR2023-07-11
00817463025972Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463025989Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026054Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026061Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026092Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026177Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026245Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026283Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026290Oakworks MedicalOAKWORKS, INC.IXR2023-07-10