Powered Laser Surgical Instrument-APOLLO IV+ Medic

GUDID 06970285176025

Beijing Syntech Laser Co., Ltd.

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID06970285176025
NIH Device Record Key66a2056b-bac7-4c6e-bcd0-572f5ea4f70c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowered Laser Surgical Instrument-APOLLO IV+ Medic
Version Model NumberMLP-02
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
GS106970285176025 [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 Date2017-06-30

On-Brand Devices [Powered Laser Surgical Instrument-APOLLO IV+ Medic]

06970285176148MLP-10
06970285176025MLP-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.