OrionTM

GUDID 00847536027107

MICROCATHETER 105-5098-150 V02 ORION

Micro Therapeutics, Inc.

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.

00763000845315 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-1-HELIX V14
00763000845322 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-2-HELIX V14
00763000845339 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-3-HELIX V14
00763000845346 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-4-HELIX V14
00763000845353 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-1-HELIX V14
00763000845360 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-2-HELIX V14
00763000845377 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-3-HELIX V14
00763000845384 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-4-HELIX V14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.