GORE Embolic Filter GEFA015185

GUDID 00733132618279

5MM FILTER ON 185CM GUIDEWIRE

W. L. Gore & Associates, Inc.

Embolic protection filtering guidewire
Primary Device ID00733132618279
NIH Device Record Key5d8a13ba-e7f8-4b1a-bc73-48b03ff696e4
Commercial Distribution Discontinuation2019-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGORE Embolic Filter
Version Model NumberGEFA015185
Catalog NumberGEFA015185
Company DUNS967358115
Company NameW. L. Gore & Associates, 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 Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132618279 [Primary]

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 Number6
Public Version Date2019-12-12
Device Publish Date2017-02-13

On-Brand Devices [GORE Embolic Filter]

007331326182867MM FILTER ON 300CM GUIDEWIRE
007331326182795MM FILTER ON 185CM GUIDEWIRE
H373GEFA015300395MM FILTER ON 300CM GUIDEWIRE
007331326182557MM FILTER ON 185CM GUIDEWIRE

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