Home GUDID 00860003987353 Speed-Torque®
Primary DI 00860003987353
Brand Speed-Torque®
Company Vascugenix, LLC
Model VSXT001
Device description Speed-Torque® Device Pouch
Published 2022-11-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name PTL Wire, Guide, Catheter, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PTL Wire, Guide, Catheter, Exempt Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860003987350 Package GS1 10 In Commercial Distribution 20860003987357 Package GS1 4 In Commercial Distribution 00860003987353 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 10860003987350 10860003987350 20860003987357 20860003987357 00860003987353 00860003987353 860003987353 0860003987353
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 117166275 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 36927675513480 RADIFOCUS Terumo Medical Products (Hangzhou) Co., Ltd. PTL 2022-12-08 00860003987360 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 10860003987350 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 10860003987367 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 06947358544302 Sunmed guidewire torque device Sunny Medical Device (Shenzhen) Co., Ltd. PTL 2022-01-04 00860003987315 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987322 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987339 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987346 Speed Torque Vascugenix, LLC PTL 2021-02-03 00884450458068 SeaDragon2™ Merit Medical Systems, Inc. PTL 2020-08-14 10884450458065 SeaDragon2™ Merit Medical Systems, Inc. PTL 2020-08-14 06936733735923 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735930 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735947 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735954 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735961 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735978 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736043 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736050 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736067 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736074 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736081 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736098 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733735937 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733735951 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733735968 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736040 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736064 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736088 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 00884450007792 Pin Vise Merit Medical Systems, Inc. PTL 2016-09-26
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