Home GUDID 00841494100162 Large Sapphire Optic
Primary DI 00841494100162
Brand Large Sapphire Optic
Company Cynosure, LLC
Model 3520C-0002R
Device description Vectus Large Sapphire Optic Refurbished
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GEX Powered laser surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841494100162 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841494100162 00841494100162 841494100162 0841494100162
GMDN Terms# Term, Definition table Term Definition Dermatological Raman spectroscopy system A mains electricity (AC-powered) device assembly intended to be used by a healthcare professional to non-invasively evaluate a skin lesion clinically suspicious for carcinoma (e.g., melanoma, squamous cell) and precursors, before making a decision to biopsy, that operates based on inelastic (Raman) scattering of monochromatic light to measure molecular vibrations and identify pathology associated tissue molecules (e.g., proteins, lipids). It is an optical system applied to the skin surface typically consisting of a hardware unit (e.g., diode laser, fibreoptic system, Raman probe, spectrograph, image sensor chip, detector, computer), software, and a connected probe used to scan the lesion.
Regulatory Flags# DUNS number 780318028 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841494100032 SculpSure laser assembly 100-7026-010 2017-07-26 00841494100049 SculpSure Applicator 100-7026-100 2017-07-26 00841494106867 SculpSure Applicator, Refurbished R100-7026-100 2017-07-24 00841494107468 ASSY, MASK FLEX CIRCUIT, MED, SUB 100-7026-816 2017-09-26 00841494107956 ASSY, FINAL LASER, SCULPSURE, SUB ONLY 100-7026-910 2017-11-29 00841494107963 ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL 100-7026-920 2017-11-29 00841494107994 RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY R100-7026-910 2018-01-18 00841494100025 Focus Cap Array 100-7012-055 2016-09-24 00841494100001 PicoSure 100-7012-010 2016-09-24 00841494100056 Elite MPX 100-7009-010 2016-09-24 00841494100063 Elite+ 100-7018-010 2016-09-24 00841494100070 Apogee+ 100-7018-290 2016-09-24 00841494100100 Accolade 100-7008-010 2016-09-24 00841494100551 Spacer tip, handpiece 130-7012-324 2016-09-24 00841494100568 Spacer tip for 532 Handpiece 130-7012-490 2016-09-24 00841494103354 532 Lite Handpiece 659-0644 2016-09-24 00841494103583 PicoSure 1064 nm Handpiece 100-7012-079 2016-09-24 00841494103590 PicoSure 532 nm Handpiece 100-7012-076 2016-09-24 00841494103675 Elite+ / Elite MPX Treatment Tip 100-7018-100 2016-09-24 00841494106775 SculpSure, Laser Assembly, Brazil 100-7026-020 2017-07-24
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