AccessGUDID - DEVICE: Repl. Cover (Dark Gray), SA-8Hr, VelaShape II (07290109950761)

GUDID

Device Identifier (DI) Information

Brand Name: Repl. Cover (Dark Gray), SA-8Hr, VelaShape II
Version or Model: AS81221
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS81221
Company Name: SYNERON MEDICAL LTD

Primary DI Number: 07290109950761
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532685716 *Terms of Use

Device Description: Repl. Cover (Dark Gray), SA-8Hr, VelaShape II

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

[?]

Product Code	Product Code Name
NUV	Massager, Vacuum, Light Induced Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071872	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: e9e289a9-ad0f-4cac-a63d-5de5b012efe6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016