AccessGUDID - DEVICE: INDIBA DEEP CARE - ELITE NS (08434251000250)

GUDID

Device Identifier (DI) Information

Brand Name: INDIBA DEEP CARE - ELITE NS
Version or Model: IDC0309USA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IDC0309USA
Company Name: INDIBA SA.

Primary DI Number: 08434251000250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 460060916 *Terms of Use

Device Description: Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories

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):	Yes
Kit:	No
Combination Product:	Yes
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?
45218	Radio-frequency skin contouring system generator	A device that is part of a skin contouring system that generates radio-frequency (RF) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within body tissues to contour both the skin and underlying tissues through a process of skin regrowth and tightening and local fat cell alteration/destruction. The energy generated by this device is conducted through dedicated applicators that are moved across a patient's skin by professional personnel for treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBX	Massager, vacuum, radio frequency induced heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161458	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: acfa1d3b-14b7-482c-a2a0-7347b9869c69
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 22, 2019