Ibramed - HF Ibramed is a portable high frequency piece of - Ibramed Industria Brasileira de Equipamentos Medicos Eir

Duns Number:903359565

Device Description: HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and 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.

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More Product Details

Catalog Number

1007011

Brand Name

Ibramed

Version/Model Number

HF IBRAMED

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KCX

Product Code Name

Epilator, High Frequency, Tweezer-Type

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IBRAMED INDUSTRIA BRASILEIRA DE EQUIPAMENTOS MEDICOS EIR" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 11