FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463026436
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Urology Table Drape
Device description
Clear PVC drape for use on Oakworks CFUR Table: 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
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463026436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463026436008174630264368174630264360817463026436

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, reusableA noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. 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
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
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
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
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 Medical OAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026429Oakworks 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