Sonicator 718

Basic Information

• Brand Name: Sonicator 718
• Primary DI: 00816864020265
• Version / Model: ME 718
• Catalog Number: ME 718
• 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: 0cec98ab-88e5-40bf-8ab1-a25a72557761

Device Description

Sonicator 718, 1 MHz, 5.5 cm2, portable ultrasound

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: 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
IMI	Ultrasonic diathermy for use in applying therapeutic deep heat	Physical Medicine	890.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11248	Physical therapy ultrasound system	An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816864020265	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112520	000

Device Sizes

Type	Value	Unit	Text
Weight	202	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 167 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Operating Temperture: 50-104 F