Home GUDID 00836462012479 Axium
Primary DI 00836462012479
Brand Axium
Company Micro Therapeutics, Inc.
Model QC-14-40-HELIX
Device description QC-14-40-HELIX BARE AXIUM HELIX COIL
Published 2015-10-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HCG DEVICE, NEUROVASCULAR EMBOLIZATION KRD Device, Vascular, for Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCG Device, Neurovascular Embolization Neurology 2 KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00836462012479 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 00836462012479 00836462012479 836462012479 0836462012479
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization coil A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; 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 Length 0 Outer Diameter 0
Regulatory Flags# DUNS number 826110710 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 10886704076957 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076957 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704076971 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704076971 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076988 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704076988 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077022 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077022 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077039 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077039 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077046 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077046 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077077 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077077 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077176 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077176 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077183 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077183 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077299 DELTAXSFT Cerenovus, Inc. HCG 2016-11-16 10886704077299 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704077374 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704077374 DELTAXSFT Cerenovus, Inc. HCG 2016-11-16 10886704076933 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076933 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704076940 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076940 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077091 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077091 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077114 DELTAFILL Cerenovus, Inc. HCG 2016-11-16 10886704077114 DELTAFILL Cerenovus, Inc. KRD 2016-11-16
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