AccessGUDID - DEVICE: Solaris Soundhead (10660584000185)

GUDID

Device Identifier (DI) Information

Brand Name: Solaris Soundhead
Version or Model: 9GSH02
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dynatronics Corporation

Primary DI Number: 10660584000185
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 113399125 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40774	Physical therapy ultrasound system applicator, hand-held	A hand-held component of a physical therapy ultrasound system that includes a transducer 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031329	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 2 Square centimeter

Device Record Status

Public Device Record Key: bf7f62ad-4d6f-44bc-adc7-7b3284bafaac
Public Version Date: April 04, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016