SPACER BI40000015 O-ARM PATIENT SPACER

SPACER BI40000015 O
O-ARM® - BI40000015

A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OWB

Device Name: Interventional Fluoroscopic X-Ray System

Device Class: 2

Physical State: Fluoroscopic X-Ray system

Definition: Interventional fluoroscopy

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluoroscopy

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human body

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00613994416209

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A