Home GUDID 00190446780335 CHATTANOOGA
Primary DI 00190446780335
Brand CHATTANOOGA
Company DJO, LLC
Model 15-0163
Device description G16 ULTRASOUND APPLICATOR 10 CM2 USA
Published 2023-09-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name IMG Stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190446780335 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190446780335 00190446780335 190446780335 0190446780335
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 081840873 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190446748427 CHATTANOOGA DJO, LLC IMG 2023-10-27 00190446750611 CHATTANOOGA DJO, LLC IMG 2023-10-27 00190446750628 CHATTANOOGA DJO, LLC IMG 2023-10-27 00190446780304 CHATTANOOGA DJO, LLC IMG 2023-09-04 00190446780311 CHATTANOOGA DJO, LLC IMG 2023-09-04 00190446780328 CHATTANOOGA DJO, LLC IMG 2023-09-04 00858703006139 OmniVersa ACCELERATED CARE PLUS CORP IMG 2023-08-17 00190446780618 CHATTANOOGA DJO, LLC IMG 2023-04-25 00190446750598 CHATTANOOGA DJO, LLC IMG 2022-09-02 00190446750604 CHATTANOOGA DJO, LLC IMG 2022-09-02 00190446757214 CHATTANOOGA DJO, LLC IMG 2022-09-02 00190446757221 CHATTANOOGA DJO, LLC IMG 2022-09-02 08908008085413 Johari Digital Healthcare Ltd. JOHARI DIGITAL HEALTHCARE LIMITED IMG 2021-06-04 08908008085420 Johari Digital Healthcare Ltd. JOHARI DIGITAL HEALTHCARE LIMITED IMG 2021-06-04 00092237902523 Winner Evo CM2 - 120V COMPASS HEALTH BRANDS CORP. IMG 2019-11-05 00092237901052 CM4 Winner Evo Device - 220V Compass Richmar, LLC IMG 2018-09-27 00092237901120 AutoSound Hands Free US Applicator Compass Richmar, LLC IMG 2018-09-27 00852515007032 THERATOUCH Compass Richmar, LLC IMG 2016-11-21 00852515007049 AUTOSOUND Compass Richmar, LLC IMG 2016-11-21 00852515007735 Winner EVO Combo Compass Richmar, LLC IMG 2016-11-21 05056119700008 Ultratone ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED IMG 2016-10-25 80092237611544 N/A COMPASS HEALTH BRANDS CORP. IMG 2016-10-13 80092237611568 LG Med Supply COMPASS HEALTH BRANDS CORP. IMG 2016-10-13 80092237611636 N/A COMPASS HEALTH BRANDS CORP. IMG 2016-10-13 80092237616808 N/A COMPASS HEALTH BRANDS CORP. IMG 2016-10-13 80092237618864 Mountain Valley COMPASS HEALTH BRANDS CORP. IMG 2016-10-13 80092237616433 N/A Roscoe Medical IMG 2016-10-12 80092237616747 N/A Roscoe Medical IMG 2016-10-12 00092237618219 N/A Roscoe Medical IMG 2016-10-12 00092237618226 N/A Roscoe Medical IMG 2016-10-12