GUDID 00763000300265

TRACKER 9734683 NAVLOCK UNIVERSAL ORANGE

MEDTRONIC NAVIGATION, INC.

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 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 ID00763000300265
NIH Device Record Key5212e0ed-cfb5-485a-8007-05f2f66ed32e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9734683
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
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
GS100763000300265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


[00763000300265]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-08

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

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
00763000616502 - O-arm O22024-05-06 O-ARM SYS BI70002000 O2 UE 240V H EN ENA^
00763000922405 - Medtronic2024-05-06 INST SET 9733935 CRANIAL PASSIVE
20643169868131 - O-ARM®2024-04-15 MOUSE 9732721 STERILE O-ARM 10
00763000768744 - StealthStation S82023-12-05 SW KIT 9735736 S8 2.1 ENT
00763000768867 - StealthStation S82023-12-05 SW KIT 9735740 S8 2.1 SPINE
00763000768980 - StealthStation S82023-12-05 SW KIT 9735919 S8 2.1 SPINE PLAN STATION

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