MAJ-1072 R/L KNOB ATTACHMENT 140 SERIES

MAJ
RIGHT/LEFT ANGULATION KNOB ATTACHMENT - MAJ-1072

A hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide
• Moist Heat or Steam Sterilization
• High-level Disinfectant

Code: FET

Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Device Class: 2

Physical State: May include: ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.

Definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted through endoscope.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in gi and gu tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170150852

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