Ultrasound Product Line Accessory

Basic Information

• Brand Name: Ultrasound Product Line Accessory
• Primary DI: 00817463027112
• Version / Model: 63487
• Company Name: OAKWORKS, INC.
• Labeler DUNS: 130256837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-06
• Public Version: 1
• Public Version Date: 2023-12-14
• Public Version Status: New
• Public Device Record Key: 3858a1cd-dde4-4d3c-a293-44a68ca66f6c

Device Description

Ultrasound EA Table Extender 63487 817463027112

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66492	Radiology table extension	A non-powered attachment to a radiology table intended to increase (lengthen) the area of flat tabletop for patient adaptation/examination (e.g., to accommodate a tall patient or to replace a contoured headrest during neck examination); it is not primarily intended for interventional procedures/surgery. It is a flat padded device with tabletop connection rods; it is not a dedicated foot or head rest.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817463027112	GS1