NUERA TIGHT

GUDID 08052049500111

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 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 Radio-frequency skin contouring system

Primary Device ID	08052049500111
NIH Device Record Key	21553110-694b-4f45-b5e0-681f55e773bc
Commercial Distribution Status	In Commercial Distribution
Brand Name	NUERA TIGHT
Version Model Number	APMD145-1ch.US
Company DUNS	443571203
Company Name	BIOS SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052049500111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151296

FDA Product Code

PBX	Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-07-07
Device Publish Date	2020-06-29

On-Brand Devices [NUERA TIGHT]

08052049500104	APMD140
08052049500111	APMD145-1ch.US