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: Not in Commercial Distribution
Catalog Number: AS81221
Company Name: SYNERON MEDICAL LTD

Primary DI Number: 07290109950761
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2023
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44832	Multi-modality skin/body contouring system	An assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum.	Active	false

FDA Product Code

[?]

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

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: e9e289a9-ad0f-4cac-a63d-5de5b012efe6
Public Version Date: June 30, 2025
Public Version Number: 5
DI Record Publish Date: September 26, 2016