Home GUDID 00818053022760
HYBRID Guidewire
Primary DI 00818053022760
Brand HYBRID Guidewire
Company BALT USA LLC
Model HYBRID008J
Device description HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
Published 2018-12-01
Public version status New
Distribution status 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 DQX Wire, Guide, Catheter MOF Guide, Wire, Catheter, Neurovasculature
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQX Wire, Guide, Catheter Cardiovascular 2 MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00818053022760 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 00818053022760 00818053022760 818053022760 0818053022760
GMDN Terms# Term, Definition table Term Definition Cardiac/peripheral vascular guidewire, single-use A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry place at room temperature and away from light
Regulatory Flags# DUNS number 945543689 Device count 1 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 00840303712053 Prestige Coil System PRESPACK30 N/A 2026-07-14 00840303712077 Prestige Coil System PRESPACK65 N/A 2026-07-14 00840303712091 Prestige Coil System PRESPACK55 N/A 2026-07-14 00840303712107 Prestige Coil System PRESPACK55 N/A 2026-07-14 00840303714521 Optima Coil System (OptiOne Coil System) OPTIONE4S N/A 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) OPTIONE4M N/A 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) OPTIONE4L N/A 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) OPTIONE45S N/A 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) OPTIONE45M N/A 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) OPTIONE45L N/A 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) OPTIONE5S N/A 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) OPTIONE5M N/A 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) OPTIONE5L N/A 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) OPTIONE5XL N/A 2026-07-06 00840303714620 Optima Coil System (OptiOne Coil System) OPTIONE55S N/A 2026-07-06 00840303714637 Optima Coil System (OptiOne Coil System) OPTIONE55M N/A 2026-07-06 00840303714644 Optima Coil System (OptiOne Coil System) OPTIONE55L N/A 2026-07-06 00840303714651 Optima Coil System (OptiOne Coil System) OPTIONE55XL N/A 2026-07-06 00840303714668 Optima Coil System (OptiOne Coil System) OPTIONE6S N/A 2026-07-06 00840303714675 Optima Coil System (OptiOne Coil System) OPTIONE6M N/A 2026-07-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06936733736951 ULTRASKIN Lepu Medical Technology (Beijing) Co.,Ltd. DQX 2026-07-10 00884450529348 SplashWire™ Merit Medical Systems, Inc. DQX 2026-07-07 06947358524021 Sunmed™ guide wires Sunny Medical Device (Shenzhen) Co., Ltd. DQX 2026-07-07 06947358535454 Sunmed™ guide wires Sunny Medical Device (Shenzhen) Co., Ltd. DQX 2026-07-07 06971428595857 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595857 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595864 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595864 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595871 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595871 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595888 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595888 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595895 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595895 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595901 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595901 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595918 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595918 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 06971428595925 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. DQX 2026-07-03 06971428595925 DCwire™ Shanghai Achieva Medical Suzhou Co., Ltd. MOF 2026-07-03 00816349014994 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015007 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015014 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015021 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015038 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015045 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015052 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015069 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015076 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26 00816349015083 CPS Courier Guidewire BRIVANT LIMITED DQX 2026-06-26