N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00817438024597
• Version / Model: R50-51N
• Company Name: Omega Surgical Instruments Inc
• Labeler DUNS: 808825038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-02
• Public Version: 2
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 0766818b-fa10-41b3-9b76-3a0dc1a26670

Device Description

5.0 MM X 2.35 MM X 44.5 MM ROUND CARBIDE BUR W/J-NOTCH, 8 FLUTE

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45553	Orthopaedic bur, single-use	A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817438024597	GS1

Customer Contacts

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