Long Pulsed Laser

GUDID 08800088900009

ELEMENIC CO.,LTD.

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Primary Device ID	08800088900009
NIH Device Record Key	66ce4776-b25a-4cb0-be16-c38e9bcd5c91
Commercial Distribution Status	In Commercial Distribution
Brand Name	Long Pulsed Laser
Version Model Number	ELEMENT-TL
Company DUNS	694716279
Company Name	ELEMENIC CO.,LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800088900009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180224

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-07
Device Publish Date	2023-03-30