O-ARM®

GUDID 00763000355579

O-ARM SYS BI70002000 O2 UE 240V G EN EN

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
Primary Device ID00763000355579
NIH Device Record Keyfd219330-51ef-4771-ba97-145b31d71aa5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000355579 [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 Date2021-08-09
Device Publish Date2021-07-30

On-Brand Devices [O-ARM®]

00643169980976O-ARM RFB BI70002000 O2 UE 120V B EN UEN
00643169869844KIT SVC O2 BI71000547 COMP MVS SER 4.0.2
00643169845091OARM BI70000028120 SYS 120V U
00643169639683O-ARM SYS BI70002000 O2 UE 120V B EN UEN
00643169589292OARM BI70000028120R SYS 120V ENGLISH RWK
00643169353428OARM BI70000028120 SYS 120V ENGLISH
00763000132378O-ARM SYS BI70002000 O2 UE 120V B EN UEN
00763000068097O-ARM SYS BI70002000 O2 UE 120V B EN EN
00763000068066O-ARM SYS BI70002000 O2 UE 120V B EN EN
00643169625228OARM BI70000028120 USED SYS 120V ENGLISH
00613994416209SPACER BI40000015 O-ARM PATIENT SPACER
20885074546203DRAPE 9732722 TUBE STERILE O-ARM 20PK
20885074546180MOUSE 9732721 STERILE O-ARM 10PK
20643169803040DRAPE 9733023 BAR STERILE O-ARM 20PK
20643169803026DRAPE 9732722 TUBE STERILE O-ARM 20PK
20643169803002MOUSE 9732721 STERILE O-ARM 10
20643169525874MOUSE BI90000048 OARM WIRELESS 10PK
20613994120322DRAPE 9733023 BAR STERILE O-ARM 20PK
00763000074050O-ARM SYS BI70002000 O2 UE 240V F DE DE
00763000134518O-ARM SYS BI70002000 O2 AD 240V I EN EN
00643169983021O-ARM RFB BI70002000 O2 UE 120V B EN UEN
00763000355555O-ARM SYS BI70002000 O2 UE 120V B EN UEN
00763000355609O-ARM SYS BI70002000 O2 UE 240V F EN EN
00763000355579O-ARM SYS BI70002000 O2 UE 240V G EN EN
00763000542849O-ARM SYS BI70002000 O2 UE 120V B EN UEN
00763000584115O-ARM RFB BI70002000 O2 UE 120V B EN UEN
00763000528133O-ARM RFB BI70002000 O2 UE 120V B EN UEN

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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