Small Sapphire Optic

GUDID 00841494100148

Vectus Small Sapphire Optic

Cynosure, Inc.

Dermatological Raman spectroscopy system
Primary Device ID00841494100148
NIH Device Record Key5ce3e810-7c02-4f8f-a7f6-b1f60cdd0877
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Sapphire Optic
Version Model Number3520A-0003
Company DUNS780318028
Company NameCynosure, Inc.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494100148 [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 Number4
Public Version Date2018-12-21
Device Publish Date2016-09-24

On-Brand Devices [Small Sapphire Optic]

00841494100636Vectus Small Sapphire Optic Refurbished
00841494100148Vectus Small Sapphire Optic

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