RadiaLux™

Basic Information

• Brand Name: RadiaLux™
• Primary DI: 00763000432805
• Version / Model: 50-101-1
• Company Name: MEDTRONIC NAVIGATION, INC.
• Labeler DUNS: 835233107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-22
• Public Version: 1
• Public Version Date: 2021-02-01
• Public Version Status: New
• Public Device Record Key: ad1d7d46-5c87-46dd-8da9-6fd1e946fcaf

Device Description

RETRACTOR 50-101-1 RADIALUX CE PINK

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: Yes
• 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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47991	Self-retaining surgical retractor, single-use	A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000432805	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity