Heli-FX™ Thoracic EndoAnchor™ System

GUDID 00763000645168

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

MEDTRONIC VASCULAR, INC.

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID00763000645168
NIH Device Record Keydfddfee1-58de-4be6-a252-fe30cbeb3641
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeli-FX™ Thoracic EndoAnchor™ System
Version Model NumberHG-18-90-32
Company DUNS080009661
Company NameMEDTRONIC VASCULAR, 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter
Length32 Millimeter
Length90 Centimeter
Outer Diameter6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000645168 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-31
Device Publish Date2022-10-22

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

00763000645175GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU
00763000645168GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
00763000645151GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU
00763000645144ACC HA-18-114 TAA APPL-CASS 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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