STANDARD BITE BLOCKS, 3 PIECES


Product Overview

STANDARD BITE BLOCKS, 3 PIECES
N/A - OF-Z5K


Device Description

A non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
  • Sound Waves
    • Ethylene Oxide
    • Sound Waves


    Product Codes

    Code: FDS

    Device Name: Gastroscope And Accessories, Flexible/Rigid

    Device Class: 2

    Physical State: endoscope, accessories associated with gastroscope

    Definition: To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (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: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Inserted orally into the stomach

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: stomach

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 04961333244171

    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


    Device Id: 14961333244178

    Device Type: Unit of Use

    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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