Wirion Retrieval Catheter P4-9-0703

GUDID 72900155120301

The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.

GARDIA MEDICAL LTD

Embolic protection filtering guidewire
Primary Device ID72900155120301
NIH Device Record Keyfade4bd2-0e60-4d7f-a2e9-897760d6d242
Commercial Distribution StatusIn Commercial Distribution
Brand NameWirion Retrieval Catheter
Version Model NumberP4-9-0703
Catalog NumberP4-9-0703
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 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

Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emaileitan@allium-medical.com
Phone+97246277166
Emailinfo@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
GS107290015512039 [Primary]
GS172900155120301 [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

Devices Manufactured by GARDIA MEDICAL LTD

72900155120103 - Wirion System kit Finished Good2019-04-09 The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is
72900155120202 - Wirion Delivery Catheter2019-04-09 The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Delivery Catheter: Contains and del
07290015512015 - Wirion System kit Finished Good2019-04-09 The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is
07290015512022 - Wirion Delivery Catheter2019-04-09 The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Delivery Catheter: Contains and deli
72900155120301 - Wirion Retrieval Catheter2019-04-09The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
72900155120301 - Wirion Retrieval Catheter2019-04-09 The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter U

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