O-ARM®

GUDID 00763000584115

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

MEDTRONIC NAVIGATION, INC.

Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00763000584115
• NIH Device Record Key: 0eccaaed-1c3b-4a76-836b-58bf485177bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-ARM®
• Version Model Number: BI70002000
• Company DUNS: 803580559
• Company Name: MEDTRONIC NAVIGATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000584115 [Primary]

FDA Product Code

• OWB: Interventional fluoroscopic x-ray system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [O-ARM®]

• 00643169980976: O-ARM RFB BI70002000 O2 UE 120V B EN UEN
• 00643169869844: KIT SVC O2 BI71000547 COMP MVS SER 4.0.2
• 00643169845091: OARM BI70000028120 SYS 120V U
• 00643169639683: O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00643169589292: OARM BI70000028120R SYS 120V ENGLISH RWK
• 00643169353428: OARM BI70000028120 SYS 120V ENGLISH
• 00763000132378: O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000068097: O-ARM SYS BI70002000 O2 UE 120V B EN EN
• 00763000068066: O-ARM SYS BI70002000 O2 UE 120V B EN EN
• 00643169625228: OARM BI70000028120 USED SYS 120V ENGLISH
• 00613994416209: SPACER BI40000015 O-ARM PATIENT SPACER
• 20885074546203: DRAPE 9732722 TUBE STERILE O-ARM 20PK
• 20885074546180: MOUSE 9732721 STERILE O-ARM 10PK
• 20643169803040: DRAPE 9733023 BAR STERILE O-ARM 20PK
• 20643169803026: DRAPE 9732722 TUBE STERILE O-ARM 20PK
• 20643169803002: MOUSE 9732721 STERILE O-ARM 10
• 20643169525874: MOUSE BI90000048 OARM WIRELESS 10PK
• 20613994120322: DRAPE 9733023 BAR STERILE O-ARM 20PK
• 00763000074050: O-ARM SYS BI70002000 O2 UE 240V F DE DE
• 00763000134518: O-ARM SYS BI70002000 O2 AD 240V I EN EN
• 00643169983021: O-ARM RFB BI70002000 O2 UE 120V B EN UEN
• 00763000355555: O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000355609: O-ARM SYS BI70002000 O2 UE 240V F EN EN
• 00763000355579: O-ARM SYS BI70002000 O2 UE 240V G EN EN
• 00763000542849: O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000584115: O-ARM RFB BI70002000 O2 UE 120V B EN UEN
• 00763000528133: O-ARM RFB BI70002000 O2 UE 120V B EN UEN
• 20643169868131: MOUSE 9732721 STERILE O-ARM 10