FEMINESS

GUDID 08052049500197

BIOS SRL

Radio-frequency skin contouring system
Primary Device ID08052049500197
NIH Device Record Key41bc0e1a-088e-4fa8-8f4d-b812ceff5f86
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEMINESS
Version Model NumberAPMD145-FEM.US
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
GS108052049500197 [Primary]

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-10
Device Publish Date2021-11-02

Devices Manufactured by BIOS SRL

08052049500234 - Splendor X2024-07-10
08052049500241 - Splendor X2024-07-10
08052049500258 - Splendor X2024-07-10
08052049500265 - Splendor X2024-07-10
08052049500289 - OptiPLUS2023-11-14
08052049500272 - OptiPLUS2023-08-31
08052049500227 - OptiStream2022-10-12
08052049500210 - NUERA TIGHT 1ch Paris Edition2022-07-14

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