OSCAR

Basic Information

• Brand Name: OSCAR
• Primary DI: 05060201560531
• Version / Model: 1
• Catalog Number: OBE2000
• 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: 5c338403-d3cc-40d2-a2b6-82b6a4db3d66

Device Description

Bonecutter - Extension Bar

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: No
• 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
37065	Ultrasonic orthopaedic cement extractor	A hand-operated, electrically-powered surgical instrument that uses ultrasonic energy for the extraction of orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include an aspirating device for the removal of cement/bone fragments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060201560531	GS1

Customer Contacts

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