Powered Laser Surgical Instrument-Trixel CO2 Laser

GUDID 06970285179026

Beijing Syntech Laser Co., Ltd.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID06970285179026
NIH Device Record Key5524dd6e-868f-4224-97da-352311af3e71
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowered Laser Surgical Instrument-Trixel CO2 Laser
Version Model NumberCFL-10
Company DUNS528741132
Company NameBeijing Syntech Laser Co., 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970285179026 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-29

Devices Manufactured by Beijing Syntech Laser Co., Ltd.

06970285174281 - Powered Laser Surgical Instrument-Diode Laser2018-08-13
06970285174168 - Powered Laser Surgical Instrument-Diode Laser Mode2018-07-06
06970285176018 - Powered Laser Surgical Instrument-APOLLO V+ Medica2018-07-06
06970285176025 - Powered Laser Surgical Instrument-APOLLO IV+ Medic2018-07-06
06970285176049 - Powered Laser Surgical Instrument-Nice Station Lig2018-07-06
06970285176148 - Powered Laser Surgical Instrument-APOLLO IV+ Medic2018-07-06
06970285179026 - Powered Laser Surgical Instrument-Trixel CO2 Laser2018-07-06
06970285179026 - Powered Laser Surgical Instrument-Trixel CO2 Laser2018-07-06
06970285179057 - Powered Laser Surgical Instrument-Trixel II CO2 La2018-07-06

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