Evident

Basic Information

• Brand Name: Evident
• Primary DI: 10884524002583
• Version / Model: VTS1737
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: e9799b9c-66e0-486e-b7c4-af25a1a4930e

Device Description

MWA Surgical Antenna

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40792	Microwave hyperthermia system applicator, intracorporeal	A component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884524002583	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011676	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Radiating Section,3.7,Centimeter;
Length	17	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -34 – 65 Degrees Celsius