Ultrasound Applicator 7410

Basic Information

• Brand Name: Ultrasound Applicator 7410
• Primary DI: 00816864020609
• Version / Model: 7410
• Catalog Number: 7410
• Company Name: METTLER ELECTRONICS CORP.
• Labeler DUNS: 008513913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7cc19e21-36d3-41a5-b25e-10bd299deae1

Device Description

740 ultrasound applicator; 10 cm sq., 1 MHz

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
IMG	STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	Physical Medicine	890.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40774	Physical therapy ultrasound system applicator	A hand-held component of a physical therapy ultrasound system that includes a transdcer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair. The device is typically used with ultrasound coupling gels to ensure an adequate interface with the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816864020609	GS1

Customer Contacts

• Phone: [phone] ext. 319
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K053546	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 167 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: No