O-arm

GUDID 00763000616564

O-ARM SYS BI70002000 O2 UE 120V B EN UEN

MEDTRONIC NAVIGATION, INC.

Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital
Primary Device ID00763000616564
NIH Device Record Key1e374672-33b8-4a86-ba0a-bee6f486cdb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameO-arm
Version Model NumberBI70002000
Company DUNS803580559
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 Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000616564 [Primary]

FDA Product Code

OWBInterventional fluoroscopic x-ray system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

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
00763000769017 - StealthStation S82023-12-05 SW KIT 9735920 S8 2.1 ENT PLAN STATION
00763000769123 - StealthStation S82023-12-05 SW KIT 9736226 FLEX 2.1 ENT
00763000769192 - StealthStation S82023-12-05 SW KIT 9736350 S8 2.1 AIR
00763000769208 - StealthStation S82023-12-05 SFW KIT 9736186 STEALTH-MIDAS MR8

Trademark Results [O-arm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
O-ARM
O-ARM
78111049 3101416 Live/Registered
MEDTRONIC NAVIGATION, INC.
2002-02-26

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