SLT

GUDID 06971858360162

Jiangxi Medex Technology Co., Ltd.

General/multiple surgical diode laser system
Primary Device ID06971858360162
NIH Device Record Keyba81b06d-0c26-40a6-8112-92d88c0901ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLT
Version Model NumberSACSll
Company DUNS544457636
Company NameJiangxi Medex Technology 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971858360162 [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 Date2023-11-20
Device Publish Date2023-11-10

Devices Manufactured by Jiangxi Medex Technology Co., Ltd.

06971858360162 - SLT2023-11-20
06971858360162 - SLT2023-11-20
06971858363927 - LaserPro2022-11-25

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