GUDID 00763000053369

STRAIGHT SUCTION 9733449 EM ENT

MEDTRONIC NAVIGATION, INC.

Stereotactic surgery system probe, single-use Stereotactic surgery system probe, single-use Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device ID00763000053369
NIH Device Record Keyeb9e7c29-0cdd-44cc-af04-1fec4a68b5c4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9733449
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, 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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000053369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

[00763000053369]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00763000457365 - Medtronic Navigation2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-E
00763000457389 - Medtronic Navigation2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SC
00763000457402 - Medtronic Navigation2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SE
00763000457617 - Medtronic Navigation2024-06-17 SFW KIT 9735921 S8 DSC STEREOTX EU-SD
00763000457822 - Medtronic Navigation2024-06-17 SW KIT 9735918 S8 STEREOTX 2ND LIC EU-SC
00763000457846 - Medtronic Navigation2024-06-17 SW KIT 9735918 S8 STEREOTX 2ND LIC EU-SE
00763000849320 - StealthStation Cranial2024-05-28 SWKT 9735586 STEALTH CRANIAL 3.1.5
00763000863302 - O-arm O22024-05-28 O-ARM SYS BI70002000 O2 UE 120V B EN UEN
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