truSculpt 5 RF handpiece

GUDID 00816722022486

truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device

CUTERA, INC.

Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar Radio-frequency skin contouring system applicator, monopolar
Primary Device ID00816722022486
NIH Device Record Key42ffa416-8366-47e3-a26b-b0c5c46f9672
Commercial Distribution StatusIn Commercial Distribution
Brand NametruSculpt 5 RF handpiece
Version Model NumbertruSculpt 5 RF handpiece
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816722022486 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

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