APTUS Heli-FX®

GUDID 00643169647640

GUIDE HG-18-90-22 TAA ENDOANCH 90CM MDT

MEDTRONIC VASCULAR, INC.

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID00643169647640
NIH Device Record Key47e469e5-c315-4b8c-a78a-1942a1a2fd77
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPTUS Heli-FX®
Version Model NumberHG-18-90-22
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 Batchfalse
Serial Numbertrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *(10-40° C)(30-75% RH)
Special Storage Condition, SpecifyBetween 0 and 0 *(10-40° C)(30-75% RH)
Special Storage Condition, SpecifyBetween 0 and 0 *(10-40° C)(30-75% RH)
Special Storage Condition, SpecifyBetween 0 and 0 *(10-40° C)(30-75% RH)

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169647640 [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 Number5
Public Version Date2020-05-06
Device Publish Date2015-10-21

On-Brand Devices [APTUS Heli-FX®]

00643169647695ACC SA-85 AAA APPLIER-CASSETTE 10 MDT
00643169647664GUIDE HG-18-90-32 TAA ENDOANCH 90CM MDT
00643169647640GUIDE HG-18-90-22 TAA ENDOANCH 90CM MDT
00643169647626GUIDE HG-16-62-28 AAA ENDOANCH 62CM MDT
00643169647602ACC HA-18-114 TAA APP-CASSETTE 10 MDT
00643169647572GUIDE SG-64 AAA ENDOANCHOR 62CM MDT
00643169647565GUIDE HG-18-90-42 TAA ENDOANCH 90CM MDT

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