Oakworks, Inc.

Basic Information

• Brand Name: Oakworks, Inc.
• Primary DI: 00817463022445
• Version / Model: Interventional Supine Pillow System
• Company Name: OAKWORKS, INC.
• Labeler DUNS: 130256837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 3
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: 7557139e-500c-420c-9b38-e0d700695d5e

Device Description

Interventional Supine Pillow System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXH	Cradle, Patient, Radiologic	Radiology	892.1830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58080	Freestanding headrest, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817463022445	GS1