Wirion System kit Finished Good P2-9-0705-S

GUDID 07290015512015

The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039

GARDIA MEDICAL LTD

Embolic protection filtering guidewire
Primary Device ID07290015512015
NIH Device Record Key1539c72e-6586-4d99-a5db-76d3f0943b0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWirion System kit Finished Good
Version Model NumberP2-9-0705-S
Catalog NumberP2-9-0705-S
Company DUNS531908965
Company NameGARDIA MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015512015 [Primary]
GS172900155120103 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTETemporary Carotid Catheter For Embolic Capture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2017-02-12

On-Brand Devices [Wirion System kit Finished Good]

07290015512015The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal
72900155120103The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal

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