RAD®

Basic Information

• Brand Name: RAD®
• Primary DI: 20885074080653
• Version / Model: 1883519HR
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-09-09
• Public Version: 4
• Public Version Date: 2021-03-08
• Public Version Status: Update
• Public Device Record Key: 47d36337-bde6-4119-95ce-c67400954bf9

Device Description

BLADE 1883519HR RAD90 3PK M4 3.5MM ROTAT

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQJ	BUR, EAR, NOSE AND THROAT	Ear, Nose, Throat	874.4140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46476	Surgical saw blade, oscillating, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20885074080653	GS1
Unit of Use	00885074080659	GS1

Customer Contacts

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