FDA UDI In Commercial Distribution 🇺🇸 United States

Ibramed

DI: 07898966442957 · Model: Dermotonus Esthetic · Ibramed Industria Brasileira de Equipamentos Medicos Eir
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ibramed
Primary DI
07898966442957
Version / Model
Dermotonus Esthetic
Company Name
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Labeler DUNS
903359565
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-02-25
Public Version
1
Public Version Date
2025-03-05
Public Version Status
New
Public Device Record Key
751a7ea2-f7a3-4d5c-b3df-4ce69ea3a640

Device Description

The DERMOTONUS ESTHETIC is a microcontrolled device that offers the following therapeutic modalities: MECHANICAL MASSAGE, VACUOTHERAPY, MICRODERMABRASION through DIAMOND PEELING, RADIOFREQUENCY, RADIOFREQUENCY ASSOCIATED WITH VACUUM AND TECARTHERAPY.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ISA Massager, Therapeutic, Electric

GMDN Terms

Code Name
36560 Hand-held electric massager

Identifiers

Type ID
Primary 07898966442957