Gel-Block™ Embolization Pledgets

GUDID M20636300

Vascular Solutions, Inc.

Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived
Primary Device IDM20636300
NIH Device Record Key88648f83-8026-45fe-b953-8145356f8eba
Commercial Distribution Discontinuation2017-05-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGel-Block™ Embolization Pledgets
Version Model Number3630
Company DUNS008999906
Company NameVascular Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM20636300 [Primary]
HIBCCM20636301 [Package]
Package: [5 Units]
Discontinued: 2017-05-31
Not in Commercial Distribution

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-10-23

On-Brand Devices [Gel-Block™ Embolization Pledgets]

M206363213632
M206363103631
M206363003630

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