Home GUDID 10810170012515 Azur Pushable Helical
Primary DI 10810170012515
Brand Azur Pushable Helical
Company MICROVENTION INC.
Model 45-250806
Catalog number 45-250806
Device description Azur
Published 2015-12-29
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 KRD Device, Vascular, for Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10810170012515 Package GS1 3 In Commercial Distribution 00810170012518 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 10810170012515 10810170012515 00810170012518 00810170012518 810170012518 0810170012518
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization coil A sterile, non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
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 10886704080121 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080138 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080145 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080152 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080206 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080213 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704076957 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076971 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076988 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077022 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077039 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077046 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077077 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077176 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077183 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077299 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704077374 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704076933 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076940 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077091 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077114 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077121 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077138 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077145 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077152 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077169 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077190 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077213 MICRUSFRAME Cerenovus, Inc. KRD 2016-11-16 10886704077220 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077237 DELTAFILL Cerenovus, Inc. KRD 2016-11-16