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510(k) Data Aggregation

    K Number
    K180630
    Device Name
    PTFE SURGICAL SUTURE
    Manufacturer
    OMNIA SPA
    Date Cleared
    2018-04-06

    (28 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIA SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.
    Device Description
    PTFE SURGICAL SUTURE
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    K Number
    K132464
    Device Name
    PTFE SURGICAL SUTURE
    Manufacturer
    OMNIA SPA
    Date Cleared
    2014-02-12

    (189 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIA SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgenes. The device is not in cardiovascular surgery, ophthalmic surgery, microsurgery, and neural tissue.
    Device Description
    PTFE Surgical Suture
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    K Number
    K110724
    Device Name
    SURGICAL PROCEDURE PACKS
    Manufacturer
    OMNIA SPA
    Date Cleared
    2011-06-23

    (99 days)

    Product Code
    FYA, FXX, KKX, LRO
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIA SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Procedure Packs are kits for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.
    Device Description
    Omnia Surgical Procedure Packs are composed of disposable devices, drapes, and surgical garb intended for professional use in preparing the operating environment with protective coverings that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. The contents of these kits may include: - Surgical Gowns (various models) with or without hand towels ● - Sterile Surgical Drapes (various models) . - Face mask . - Protective caps . - Sheath/Tubing Sleeve . - Surgical aspirator with adaptor . - Surgical Gauze . - Sterile disinfection sponge and/or basin . - Adhesive Film . - Syringe (s) . - Needle(s) . - . Single-use scalpel - Small dental mirror/dental explorer/tweezer . - Bone collector ● - . Saliva ejector - . Irrigation/Infusion line - Stopcock and ramp for infusion . - Waste bag for contaminated material .
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