MOUSE 9732721 STERILE O-ARM 10

MOUSE 9732721 STERILE O
O-ARM® - 9732721

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: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OXO

Device Name: Image-Intensified Fluoroscopic X-Ray System, Mobile

Device Class: 2

Physical State: Hardware

Definition: Fluoroscopy of the human body.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: X-ray transmission through human body

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: 20643169868131

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00643169868137

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00643169868137

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