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O-arm

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name
O-arm FDA UDI
Generic Name
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
O-ARM SYS BI70002000 O2 UE 240V F DE DE FDA UDI
Model / Reference
BI70002000 FDA UDI
Description
O-ARM SYS BI70002000 O2 UE 240V F DE DE FDA UDI

Identifiers

Primary DI / UDI-DI
00643169618121 FDA UDI
FDA Product Code
OWB FDA UDI
JAA FDA UDI
OXO FDA UDI
GMDN Term
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Portable general-purpose fluoroscopic x-ray system, digital

O-arm by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable general-purpose fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Navigation, Inc.

Sources (1)

  • FDA UDI 0e3046cd-f0c1-41be-8831-ac66a93c1992 34 fields · synced Jun 8, 2026