AccessGUDID - DEVICE: Ultratone (05056119700008)

GUDID

Device Identifier (DI) Information

Brand Name: Ultratone
Version or Model: Futura Pro (US Specification)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: USFPC1
Company Name: ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED

Primary DI Number: 05056119700008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 226427250 *Terms of Use

Device Description: Futura Pro (US Specification) System comprising: Console, Body Applicator, and 1MHz Ultrasound Applicator.

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):	No
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?
17908	Physical therapy ultrasound/neuromuscular stimulation system	An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31fe3727-752c-4519-9f18-62880b146221
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 25, 2016