truSculpt 16 Hand Held

GUDID 00816722022448

truSculpt 16 Hand Held RF Handpiece for iD

CUTERA, INC.

Radio-frequency skin contouring system applicator, monopolar
Primary Device ID00816722022448
NIH Device Record Key66d856b1-6b84-429b-b05c-64d54e0f40fc
Commercial Distribution StatusIn Commercial Distribution
Brand NametruSculpt 16 Hand Held
Version Model NumbertruSculpt 16 Hand Held
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
GS100816722022448 [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 Date2018-07-30
Device Publish Date2018-06-27

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