Internal, CO2RE Intima KT76614US

GUDID 17290109950379

Internal, CO2RE Intima

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system
Primary Device ID17290109950379
NIH Device Record Keye3cb7a8a-d4dc-406a-8404-331eb98395a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameInternal, CO2RE Intima
Version Model NumberKT76614US
Catalog NumberKT76614US
Company DUNS532685716
Company NameSYNERON MEDICAL LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109950379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-26

On-Brand Devices [ Internal, CO2RE Intima]

07290109950372Internal, CO2RE Intima
17290109950379Internal, CO2RE Intima

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