X-Pedion

GUDID 00763000294113

GUIDEWIRE 103-0605-200 V08 X-PEDION-10

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual
Primary Device ID00763000294113
NIH Device Record Keye02c4241-bf0f-4397-8c49-b5e43407131e
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Pedion
Version Model Number103-0605-200
Company DUNS826110710
Company NameMicro Therapeutics, 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 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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in a dry place, away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000294113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-07-31

On-Brand Devices [X-Pedion]

0083646200322414 Hydrophilic Guidewire
0083646200317010 Hydrophilic Guidewire
00763000294113GUIDEWIRE 103-0605-200 V08 X-PEDION-10

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