Home GUDID 10860003987350 Speed-Torque®
Primary DI 10860003987350
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
Rx false
OTC false
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00860003987353 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 00860003987360 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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