10mm GlideSafe HP (3) and Cable

GUDID 00841494108298

10mm GlideSafe HP (3) and Cable

Cynosure, Inc.

Radio-frequency skin contouring system applicator, monopolar
Primary Device ID00841494108298
NIH Device Record Key7d9e9ece-5860-456c-b708-74c7ca86a20a
Commercial Distribution StatusIn Commercial Distribution
Brand Name10mm GlideSafe HP (3) and Cable
Version Model NumberP210HPD
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
GS100841494108298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-10-18
Device Publish Date2018-09-17

Devices Manufactured by Cynosure, Inc.

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00841494103774 - ICON CONTROL MODULE REMAN2022-08-15 ICON CONTROL MODULE REMAN
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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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