SB 2 capsule, 1-pack


Product Overview

SB 2 capsule, 1
PillCam - FGS-0320


Device Description

An electrically-powered, noninvasive component of a video capsule endoscopy system designed to be attached to/worn by a patient to receive the image data signals from an ingested video capsule and transmit them to the system monitor. It typically has the form of a metallic plate(s) or adhesive pad(s) with connection cables. This is a reusable device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 0.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NEZ

    Device Name: System, Imaging, Gastrointestinal, Wireless, Capsule

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    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: 876.1300

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 07290101361404

    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


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