Heli-FX™ Ancillary EndoAnchor™ Cassette

GUDID 00763000645182

ACC EC-05 ANCIL ENDOANCH CASS EIFU US

MEDTRONIC VASCULAR, INC.

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID00763000645182
NIH Device Record Keyf38ea83d-4a02-444a-8b27-5d9ebbbe2e17
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeli-FX™ Ancillary EndoAnchor™ Cassette
Version Model NumberEC-05
Company DUNS080009661
Company NameMEDTRONIC VASCULAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

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
GS100763000645182 [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

Devices Manufactured by MEDTRONIC VASCULAR, INC.

00763000645137 - Heli-FX™ EndoAnchor™ System2022-10-31 GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
00763000645144 - Heli-FX™ Thoracic EndoAnchor™ System2022-10-31 ACC HA-18-114 TAA APPL-CASS 10 EIFU US
00763000645151 - Heli-FX™ Thoracic EndoAnchor™ System2022-10-31 GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU
00763000645168 - Heli-FX™ Thoracic EndoAnchor™ System2022-10-31 GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
00763000645175 - Heli-FX™ Thoracic EndoAnchor™ System2022-10-31 GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU
00763000645182 - Heli-FX™ Ancillary EndoAnchor™ Cassette2022-10-31ACC EC-05 ANCIL ENDOANCH CASS EIFU US
00763000645182 - Heli-FX™ Ancillary EndoAnchor™ Cassette2022-10-31 ACC EC-05 ANCIL ENDOANCH CASS EIFU US
00643169647565 - APTUS Heli-FX®2020-05-06 GUIDE HG-18-90-42 TAA ENDOANCH 90CM MDT
00643169647572 - APTUS Heli-FX®2020-05-06 GUIDE SG-64 AAA ENDOANCHOR 62CM MDT

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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