Sonicator 718 ME 718

GUDID 00816864020265

Sonicator 718, 1 MHz, 5.5 cm2, portable ultrasound

METTLER ELECTRONICS CORP.

Physical therapy ultrasound system

• Primary Device ID: 00816864020265
• NIH Device Record Key: 0cec98ab-88e5-40bf-8ab1-a25a72557761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonicator 718
• Version Model Number: ME 718
• Catalog Number: ME 718
• Company DUNS: 008513913
• Company Name: METTLER ELECTRONICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com

Device Dimensions

• Weight: 202 Gram
• Weight: 202 Gram
• Weight: 202 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperture: 50-104 F
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperture: 50-104 F

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816864020265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112520

FDA Product Code

• IMI: Ultrasonic diathermy for use in applying therapeutic deep heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

Devices Manufactured by METTLER ELECTRONICS CORP.

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• 00816864020111 - TENS 210: 2019-10-23 Two-channel battery-operated TENS unit
• 00816864020128 - TENS 210T: 2019-10-23 Two-channel battery-operated TENS unit with timer
• 00816864020135 - TENS 212: 2019-10-23 Two-channel digial TENS device with LCD display
• 00816864020142 - TENS*STIM 211: 2019-10-23 Stimulator, muscle, powered, for muscle conditioning
• 00816864020401 - Trio*Stim 215: 2019-10-23 Stimulator, nerve, transcutaneous, for pain relief
• 00816864020005 - Sys*Stim 206: 2019-05-23 Powered muscle stimulator, one channel neuromuscular stimulator