Wax Coated Braided Silk


Product Overview

Wax Coated Braided Silk
Sofsilk - SS-83-M


Device Description

A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 130.00
    • N/A

  • Device Sizes

  • diameter,3/0,N/A;
  • Length: 18 Inch
    • diameter,3/0,N/A;
    • Length: 18 Inch


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GAP

    Device Name: Suture, Nonabsorbable, Silk

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    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: Y

    Target Area: N/A

    Regulation Number: 878.5030

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884521162133

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521162136

    Package Quantity: 24

    Package Discontinue Date: 10/2/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CASE


    Device Id: 10884521162136

    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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