OrionTM

GUDID 00847536027107

MICROCATHETER 105-5098-150 V02 ORION

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00847536027107
NIH Device Record Key5ceb347b-53c8-4544-a8eb-5b9f4e713010
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrionTM
Version Model Number105-5098-150
Company DUNS826110710
Company NameMicro Therapeutics, 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 Perscriptiontrue
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100847536027107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, continuous flush

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

[00847536027107]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-07-25

Devices Manufactured by Micro Therapeutics, Inc.

00847536036215 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-10 V03 VANTAGE
00847536036222 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-12 V03 VANTAGE
00847536036239 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-14 V03 VANTAGE
00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-16 V03 VANTAGE
00847536036253 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-18 V03 VANTAGE
00847536036260 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-250-20 V03 VANTAGE
00847536036277 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-275-10 V03 VANTAGE
00847536036284 - PipelineTM Vantage Embolization Device with Shield TechnologyTM2024-01-08 STENT PED3-021-275-12 V03 VANTAGE
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