Home GUDID 00850008222016 LOBO
Primary DI 00850008222016
Brand LOBO
Company OKAMI MEDICAL, INC.
Model LOBO-3
Device description Peripheral Vascular Occluder
Published 2020-01-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
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 00850008222016 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 00850008222016 00850008222016 850008222016 0850008222016
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization plug, metallic A sterile, non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Regulatory Flags# DUNS number 117045423 Device count 1 Lot or batch true Expiration date on label true 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
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