EPK-I LAMP KIT (BIOMED REPLACEMENT)

EPK
N/A - KBM86531P

A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PEA

Device Name: Endoscope, Accessories, Image Post-Processing For Color Enhancement

Device Class: 2

Physical State: The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.

Definition: Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Limited to endoscopic systems for observation of the gastro-urological tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04961333243259

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