truSculpt 3D

GUDID 00816722022431

truSculpt 3D RF Handpiece

CUTERA, INC.

Radio-frequency skin contouring system
Primary Device ID00816722022431
NIH Device Record Key3ec5c804-32d5-4893-8009-9312122337ec
Commercial Distribution StatusIn Commercial Distribution
Brand NametruSculpt 3D
Version Model NumbertruSculpt 3D
Company DUNS041071643
Company NameCUTERA, INC.
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

Customer Support Contacts

Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816722022431 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-26
Device Publish Date2017-03-27

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