Home GUDID 00859910007018 Vis-Rx
Primary DI 00859910007018
Brand Vis-Rx
Company GENTUITY LLC
Model US Catheter Kit G30-01
Device description 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US
Published 2021-02-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DQO Catheter, Intravascular, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00859910007018 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 00859910007018 00859910007018 859910007018 0859910007018
GMDN Terms# Term, Definition table Term Definition Coronary optical coherence tomography system catheter A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 1.8 French
Regulatory Flags# DUNS number 077509759 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00859910007032 Gentuity HF-OCT Imaging System SW 23.3.13 G10-01 2021-06-22 00859910007148 Vis-Rx Prime G31 G31-01 2025-04-09 00859910007049 Gentuity Gentuity Review Station G80-01 2022-08-17
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00842429108574 BOBBY/SOFIA Kit Microvention, Inc. DQO 2025-04-30 00842429108444 Sofia Microvention, Inc. DQO 2024-10-18 00842429108451 Sofia Microvention, Inc. DQO 2024-10-18 00842429108468 Sofia Microvention, Inc. DQO 2024-10-18 00763000541194 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000541200 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000541217 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000413767 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413774 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413781 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413798 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413804 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413811 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413828 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00816777025913 Sofia 5F-125cm STR Microvention, Inc. DQO 2018-08-07 00816777025920 Sofia 5F-115cm STR Microvention, Inc. DQO 2018-08-07 00857688007278 Respiguide Delivery System RESPICARDIA, INC. DQO 2018-04-30 00884450089194 EmboCath® Plus BIOSPHERE MEDICAL DQO 2017-05-11 00884450089200 EmboCath® Plus BIOSPHERE MEDICAL DQO 2017-05-11 00866749000202 Morph Universal Deflectable Guide Catheter BIOCARDIA, INC. DQO 2016-10-10 08714729200567 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200574 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200581 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200598 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200604 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200611 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200628 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200635 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200659 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200666 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24