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510(k) Data Aggregation

    K Number
    K972703
    Device Name
    REDYROB-CLOSED WOUND DRAINAGE SYSTEM
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Date Cleared
    1997-10-01

    (75 days)

    Product Code
    GCY
    Regulation Number
    878.4680
    Why did this record match?
    Product Code :

    GCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.
    Device Description
    REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.
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    K Number
    K971036
    Device Name
    ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
    Manufacturer
    INTERPORE INTL.
    Date Cleared
    1997-06-03

    (75 days)

    Product Code
    GCY
    Regulation Number
    878.4680
    Why did this record match?
    Product Code :

    GCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft. The capacity for bone collection in the screen is approximately 16 cc.
    Device Description
    The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.
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    K Number
    K963839
    Device Name
    CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1996-12-12

    (79 days)

    Product Code
    GCY
    Regulation Number
    878.4680
    Why did this record match?
    Product Code :

    GCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections.
    Device Description
    The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.
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    K Number
    K960099
    Device Name
    PENROSE DRAIN MODELS 6001 - 6007
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-03-11

    (60 days)

    Product Code
    GCY
    Regulation Number
    878.4680
    Why did this record match?
    Product Code :

    GCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
    Device Description
    Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.
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