Home GUDID 10810041650006 IMPEDE Embolization Plug
Primary DI 10810041650006
Brand IMPEDE Embolization Plug
Company SHAPE MEMORY MEDICAL INC
Model IMP-05
Catalog number IMP-05
Device description IMPEDE Embolization Plug, 5mm
Published 2020-04-02
Public version status New
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 10810041650006 Package GS1 1 In Commercial Distribution 00810041650009 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 10810041650006 10810041650006 00810041650009 00810041650009 810041650009 0810041650009
GMDN Terms# Term, Definition table Term Definition Vascular occluder, single-use A device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device.
Regulatory Flags# DUNS number 025984823 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10810041650013 IMPEDE Embolization Plug IMP-07 IMP-07 2020-04-02 10810041650020 IMPEDE Embolization Plug IMP-10 IMP-10 2020-04-02 10810041650037 IMPEDE-FX Embolization Plug IMP-FX-06 IMP-FX-06 2020-04-02 10810041650044 IMPEDE-FX Embolization Plug IMP-FX-08 IMP-FX-08 2020-04-02 10810041650051 IMPEDE-FX Embolization Plug IMP-FX-12 IMP-FX-12 2020-04-02
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