AccessGUDID - DEVICE: Dynatron 25 Series 125B (10660584000147)

GUDID

Device Identifier (DI) Information

Brand Name: Dynatron 25 Series 125B
Version or Model: D125B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynatronics Corporation

Primary DI Number: 10660584000147
Issuing Agency: GS1
Commercial Distribution End Date:
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?
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.	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 [?]
K961250	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
Weight: 4.0 Pound
Height: 4.0 Inch
Width: 7 Inch
Length: 9.0 Inch

Device Record Status

Public Device Record Key: 222d13a3-7651-4e6a-b579-f03f34476b48
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016