Home GUDID 04059497000242 FiberTech®
Primary DI 04059497000242
Brand FiberTech®
Company LEONI Fiber Optics GmbH
Model FT IR600/720HCN-3/SF-2050 003001C
Catalog number M102962S
Published 2016-09-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use 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 04059497000242 Package GS1 10 In Commercial Distribution 04059497000006 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04059497000242 04059497000242 4059497000242 04059497000006 04059497000006 4059497000006
GMDN Terms# Term, Definition table Term Definition Urogenital surgical laser system beam guide, single-use A sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.
Regulatory Flags# DUNS number 342703174 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04059497000037 CoolLipoTM CL 320 S M210273S 2016-09-29 04059497000723 CoolLipoTM CL 500 S M210608S 2016-09-29 04059497000068 FiberTech® FT IR200/240ST-3/SL-F 1500K3L M220150S 2016-09-29 04059497000075 FiberTech® FT IR272/300ST-3/SL-F 1500K3L M220200S 2016-09-29 04059497000082 FiberTech® FT IR365/400ST-3/SL-F 1500K3L M220300S 2016-09-29 04059497000099 FiberTech® FT IR550/605ST-3/SL-F 1500K3L M220500S 2016-09-29 04059497000105 CoolLipoTM CL 500 R M220522N 2016-09-29 04059497000112 CoolLipoTM CL 320 R M220921N 2016-09-29 04059497000006 FiberTech® FT IR600/720HCN-3/SF-2050 003001C M102962S 2016-09-29 04059497000198 FiberTech® FT IR600/720HCN-3/SL-SF-1750 003711C M280202S 2016-09-29 04059497000204 FiberTech® FT IR600/720HCN-3/SL-SF-2050 L12011F M280311S 2016-09-29 04059497000211 FiberTech® FT IR600/720HCN-3/SL-SF-2050 L12011F M280317S 2016-09-29 04059497000488 FiberTech® FT IR600/720HCN-3/SL-SF-2050 0S2011F M280317S 2017-08-08 04260438610028 FiberTech® FT IR600/720HCN-3/SL-SF-2000 012011L M280300S 2016-09-29 04059497000013 FiberTech® FT IR200/240ST-3/SL-F 120011L M210150S 2016-09-29 04059497000020 FiberTech® FT IR273/300ST-3/SL-F 120011L M210200S 2016-09-29 04059497000044 FiberTech® FT IR365/400ST-3/SL-F 120011L M210300S 2016-09-29 04059497000051 FiberTech® FT IR550/605ST-3/SL-F 120011L M210500S 2016-09-29 04059497000129 FiberTech® FT IR210/220A-2.5/SM-ES23 000311L M270200S 2016-09-29 04059497000136 FiberTech® FT IR200/220PI-2.5/SMI-ES23 5K0CK1F M270202S 2016-09-29
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