AccessGUDID - DEVICE: Sofwave Applicator (07290018152065)

GUDID

Device Identifier (DI) Information

Brand Name: Sofwave Applicator
Version or Model: FG00003-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG00003-R
Company Name: SOFWAVE MEDICAL LTD

Primary DI Number: 07290018152065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531962539 *Terms of Use

Device Description: This applicator is the refurbish version of the small (precise) applicator, designed to allow the user treatment flexibility and easier access to smaller and more curved areas.

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?
62436	Ultrasonic skin contouring system	A mobile assembly of electrically-powered devices intended to temporarily minimize the manifestation of cellulite, loose or wrinkled skin, and/or facial lines through the extracorporeal application of high-intensity/frequency ultrasound [e.g., high intensity focused ultrasound (HIFU)]. It is typically used on the head and neck where it generates low levels of heat in the targeted tissue to stimulate the cells for elastin/collagen production and tissue rejuvenation. It typically consists of a high-intensity/frequency generator/control unit, handpiece, transducer cartridge and connection cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191421	000
K211483	000
K223237	000
K230019	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 Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b15a8519-e327-4df8-bd27-9f2fb81f5426
Public Version Date: June 20, 2023
Public Version Number: 2
DI Record Publish Date: April 24, 2023