FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022452
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Prone Pillow
Device description
Designed to increase support for the head and neck during non-surgical procedures; intended for use by a healthcare professional
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IXRTable, Radiographic, Tilting
IZZTable, Radiographic, Non-Tilting, Powered
KXHCradle, Patient, Radiologic
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2
KXHCradle, Patient, RadiologicRadiology1
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022452008174630224528174630224520817463022452

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130256837
Device count
1
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
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