AccessGUDID - DEVICE: Ibramed (07898961579146)

GUDID

Device Identifier (DI) Information

Brand Name: Ibramed
Version or Model: HF IBRAMED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1007011
Company Name: Ibramed Industria Brasileira de Equipamentos Medicos Eir

Primary DI Number: 07898961579146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 903359565 *Terms of Use

Device Description: HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and podology application. Application frequency is monopolar, that is, only one electrode is used. The function of the gas inside the electrode is to induce the current flow. This gas is excited through the passage of electric current and produces a light, whose color depends on the type of gas used. The gas is then ionized by the high tension, making the glass bulb fluorescent.

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?
43642	Professional hair-removal electrolysis system	An assembly of devices intended to permanently remove unwanted body hair by destroying the dermal papilla (hair root) through application of an electric current at the tip of a fine needle electrode that is inserted close to the hair shaft, under the skin, and into the dermal papilla. It typically includes an electrically-powered control unit, a handpiece that connects to the control unit and holds the disposable electrode, and a foot-switch. The system is typically available in three types: galvanic (applies DC), thermolysis/high-frequency (applies AC), and blend (applies DC/AC combination). It is intended to be operated by a trained professional and may be referred to as an epilator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCX	Epilator, High Frequency, Tweezer-Type

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 18f7f028-1749-4441-963a-e1e596c80391
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: October 13, 2017