Home GUDID 00812636020457 Sofia 6F-125cm STR
Primary DI 00812636020457
Brand Sofia 6F-125cm STR
Company Microvention, Inc.
Model DA6125ST
Catalog number DA6125ST
Device description Access
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
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 00812636020457 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 00812636020457 00812636020457 812636020457 0812636020457
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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 003263105 Device count 1 DM exempt true 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 true Sterilization required before use false Other Devices From This Company# 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
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