Topical Skin Adhesive


Product Overview

Topical Skin Adhesive
SwiftSet - SS6


Device Description

A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.


Environmental Conditions

  • Special Storage Condition, Specify
    • No;

  • Device Sizes

  • Total Volume: 0.8 Milliliter
    • Total Volume: 0.8 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MPN

    Device Name: Tissue Adhesive For The Topical Approximation Of Skin

    Device Class: 2

    Physical State: N/A

    Definition: Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

    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: 878.4010

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 30884521196777

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521196773

    Package Quantity: 36

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884521196773

    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: 20884521196770

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521196773

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


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