MEDRAD® Avanta Footswitch

Basic Information

• Brand Name: MEDRAD® Avanta Footswitch
• Primary DI: 00616258025773
• Version / Model: AVA 500 FTC
• Catalog Number: AVA 500 FTC
• Company Name: BAYER MEDICAL CARE INC.
• Labeler DUNS: 058716649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-15
• Public Version: 1
• Public Version Date: 2022-04-25
• Public Version Status: New
• Public Device Record Key: 047dd7d8-9776-4f91-b1db-fea21717332b

Device Description

ASSY,FOOTSWITCH,AVANTA,LR (88104854)

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616258025773	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050456	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -25 – 75 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 100 Percent (%) Relative Humidity