Heli-FX™ EndoAnchor™ System

GUDID 00763000225995

GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU

MEDTRONIC, INC.

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID00763000225995
NIH Device Record Keyb42cd2cb-7069-4f14-a3d3-c7a3cc0fb3fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeli-FX™ EndoAnchor™ System
Version Model NumberHG-18-90-32
Company DUNS006261481
Company NameMEDTRONIC, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length90 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000225995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTDEndovascular suturing system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2019-06-29

On-Brand Devices [Heli-FX™ EndoAnchor™ System]

00763000025298TAA GUIDE DEVICE 42 EIFU
00763000025281TAA GUIDE DEVICE 32 EIFU
00763000025274TAA GUIDE DEVICE 22 EIFU
00763000025267AAA GUIDE DEVICE 28 EIFU
00763000025250AAA GUIDE DEVICE 22 EIFU
00763000006686ANCILLARY ENDOANCHOR CASSETTE US
00763000006679TAA GUIDE DEVICE 42 EIFU
00763000006662TAA GUIDE DEVICE 32 EIFU
00763000006655TAA GUIDE DEVICE 22 EIFU
00763000006648TAA APPLIER DEVICE US EIFU
00763000006631AAA GUIDE DEVICE 28 EIFU
00763000006624AAA GUIDE DEVICE 22 EIFU
00763000006617AAA APPLIER DEVICE US EIFU
00763000225971GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
00763000225964GUIDE SG-64 AAA ENDOANCHOR EIFU
00763000226008GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU
00763000225995GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
00763000225988GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU
00763000225940ACC HA-18-114 TAA APPL-CASS 10 EIFU US
00763000225933ACC SA-85 AAA APPL-CASSETTE 10 EIFU US
00763000225957ACC EC-05 ANCIL ENDOANCHOR CASSETTE US
00763000645120GUIDE SG-64 AAA ENDOANCHOR 22 EIFU US
00763000645113ACC SA-85 AAA APPL-CASSETTE 10 EIFU US

Trademark Results [Heli-FX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELI-FX
HELI-FX
85910990 not registered Dead/Abandoned
Aptus Endosystems, Inc.
2013-04-22
HELI-FX
HELI-FX
85426860 4564541 Live/Registered
MEDTRONIC VASCULAR, INC.
2011-09-20

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