AccessGUDID - DEVICE: Ibramed (07898966442964)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 07898966442964
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 903359565 *Terms of Use

Device Description: Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis.

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?
35538	Freestanding electric massager	An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRQ	Unit, Heating, Powered

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: 3eb41c89-100a-4862-82b9-d8e19ba53eae
Public Version Date: March 05, 2025
Public Version Number: 1
DI Record Publish Date: February 25, 2025