Gel-Bead™ Embolization Spheres

GUDID M20638240

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 Non-neurovascular embolization plug, animal-derived
Primary Device IDM20638240
NIH Device Record Key1be8bcd9-ce2d-4f6e-acdc-585a793ea049
Commercial Distribution StatusIn Commercial Distribution
Brand NameGel-Bead™ Embolization Spheres
Version Model Number3824
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
Phone888-240-6001
Emailcustomerservice@vasc.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM20638240 [Primary]

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 Date2019-11-11
Device Publish Date2018-02-21

On-Brand Devices [Gel-Bead™ Embolization Spheres]

M206382503825
M206382403824
M206382303823
M206382203822
M206382103821
M206382003820
M206380303803
M206380203802
M206380113801
M206380013800

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