1 mL TB LS Syringe


Product Overview

1 mL TB LS Syringe
Omnifix™ - 9161406V-02


Device Description

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Total Volume: 1.0 Milliliter
    • Total Volume: 1.0 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FMF

    Device Name: Syringe, Piston

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 880.5860

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 04046963452377

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04046963452384

    Package Quantity: 18

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04046963452384

    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: 04046964354359

    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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