OSCAR

Basic Information

• Brand Name: OSCAR
• Primary DI: 05060201560456
• Version / Model: 1
• Catalog Number: CH300
• Company Name: ORTHOSONICS LIMITED
• Labeler DUNS: 505987040
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b2fed2ea-052c-4dce-8be7-427852548d9b

Device Description

Cable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZV	System, Cement Removal Extraction	Orthopedic	888.4580	2
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	888.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44598	Orthopaedic cement extractor, electric	A hand-operated, electrically-powered surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other power operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060201560456	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]