FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463026405
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Adjustable T-Rail Clamp Accessory-6in
Device description
This clamp is designed only for use on an Oakworks CFPM product. Intended for use by a healthcare professional in a medical environment
Published
2023-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00817463026405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463026405008174630264058174630264050817463026405

GMDN Terms#

Term, Definition table
TermDefinition
Frame/rail/pole device holderA clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.

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
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
00817463026412Oakworks Medical OAKWORKS, 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
00817463026252Oakworks 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