AccessGUDID - DEVICE: EndyMed Pro Shaper Handpiece (07290016814149)

GUDID

Device Identifier (DI) Information

Brand Name: EndyMed Pro Shaper Handpiece
Version or Model: Pro Shaper Handpiece
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ND_PRD00093
Company Name: ENDYMED MEDICAL LTD

Primary DI Number: 07290016814149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531958689 *Terms of Use

Device Description: The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.

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?
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
OUH	Skin Resurfacing Rf Applicator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083461	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da2575ab-04c5-4c6e-b915-0534b10e067e
Public Version Date: March 21, 2019
Public Version Number: 3
DI Record Publish Date: December 31, 2018