Home GUDID M20636310 Gel-Block™ Embolization Pledgets
Primary DI M20636310
Brand Gel-Block™ Embolization Pledgets
Company Vascular Solutions, Inc.
Model 3631
Published 2015-10-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 M20636311 Package HIBCC 5 Not in Commercial Distribution M20636310 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization plug, animal-derived A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials 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 typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 008999906 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M20679600 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679610 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679620 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679640 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679650 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679710 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M206780500 SmartNeedle® vascular access system 78050 2016-09-06 M206780600 SmartNeedle® vascular access system 78060 2016-09-06 M206780300 SmartNeedle® vascular access system 78030 2016-09-05 M206780400 SmartNeedle® vascular access system 78040 2016-09-06 M206720000 SmartNeedle® monitor 72000 2016-09-23 M20631010 Thrombix® Hemostasis Patch topical hemostat 3101 2016-09-15 M20630100 D-Stat® 2 Dry topical hemostat 3010 2016-09-15 M20681500 Teirstein Edge™ device organizer 8150 2016-09-05 M20681510 Angio Assist™ docking station 8151 2016-09-05 M20673710 Axis™ guidewire 7371 2016-09-05 M20673720 Axis™ guidewire 7372 2016-09-05 M20674720 VSI Tru-Torque™ guidewire 7472 2016-09-05 M20674730 VSI Tru-Torque™ guidewire 7473 2016-09-05 M20674790 Amplatz SST™ guidewire 7479 2016-09-05
Other Devices Sharing Product Codes# 
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