GORE Embolic Filter GEFA017300

GUDID 00733132618286

7MM FILTER ON 300CM GUIDEWIRE

W. L. Gore & Associates, Inc.

Embolic protection filtering guidewire Embolic protection filtering guidewire
Primary Device ID00733132618286
NIH Device Record Keyace858dc-f2c3-477c-a1b2-882012d52100
Commercial Distribution Discontinuation2019-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGORE Embolic Filter
Version Model NumberGEFA017300
Catalog NumberGEFA017300
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

Length300 Centimeter
Length300 Centimeter
Length300 Centimeter
Length300 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132618286 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.