THERMI 250

GUDID 08052049500005

BIOS SRL

Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system
Primary Device ID08052049500005
NIH Device Record Key47fd4dbb-d410-4f3f-bd1c-9903d5c0b8f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHERMI 250
Version Model NumberAPMD115C
Company DUNS443571203
Company NameBIOS SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052049500005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-11-30
Device Publish Date2016-09-29

Devices Manufactured by BIOS SRL

08052049500289 - OptiPLUS2023-11-14
08052049500272 - OptiPLUS2023-08-31
08052049500227 - OptiStream2022-10-12
08052049500210 - NUERA TIGHT 1ch Paris Edition2022-07-14
08052049500135 - FEMINESS tip2021-11-10
08052049500197 - FEMINESS2021-11-10
08052049500012 - SUPERBIUM2021-08-24
08052049500005 - THERMI 2502020-11-30
08052049500005 - THERMI 2502020-11-30

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