ThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm

GUDID 00841494100445

ThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm

Cynosure, Inc.

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID00841494100445
NIH Device Record Keyaa67bcfb-a89f-48c7-b8dc-7b997b9254ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm
Version Model Number100-7007-350
Company DUNS780318028
Company NameCynosure, 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 Batchtrue
Serial Numberfalse
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
GS100841494100445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

Devices Manufactured by Cynosure, Inc.

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00841494103507 - Vectus - Base Module Reman2022-08-15 Vectus - Base Module Reman
00841494103774 - ICON CONTROL MODULE REMAN2022-08-15 ICON CONTROL MODULE REMAN
00841494100230 - ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO3002021-08-13 ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
00841494100537 - ASSY, FINAL LASER, PICO3002021-08-13 ASSY, FINAL LASER, PICO300
00841494100520 - ASSY, 1540 HANDPIECE, ICON2021-07-26 ASSY, 1540 HANDPIECE, ICON
00841494102272 - 1540 HANDPIECE ICON, REMANUFACTURED2021-07-26 1540 HANDPIECE ICON, REMANUFACTURED
00841494105105 - 60MM HANDPIECE W/ACC, TEMPSURE2021-07-26 60MM HANDPIECE W/ACC, TEMPSURE

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