SILKAM BLACK 6 (8) 150CM


Product Overview

SILKAM BLACK 6 (8) 150CM
Silkam - G0262145


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

No Data Available


Device Sizes

  • Length: 150.00 Centimeter
  • Size of Thread (USP - Others) : 6
  • Thread Material : silk
    • Length: 150.00 Centimeter
    • Size of Thread (USP - Others) : 6
    • Thread Material : silk


    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: 04038653734405

    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: 04045439041664

    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


    Device Id: 04046955113019

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04038653734405

    Package Quantity: 60

    Package Discontinue Date: 9/8/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Carton


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