Zoom Coupler, C-Mount

Product Overview

Zoom Coupler, C
1488, Ideal Eyes - 1488020125

Device Description

An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Hydrogen Peroxide
    • Hydrogen Peroxide

    Product Codes

    Code: GCJ

    Device Name: Laparoscope, General & Plastic Surgery

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU

    Device Identifiers

    Device Id: 07613327061086

    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

    Educational Resources