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510(k) Data Aggregation

    K Number
    K992732
    Device Name
    STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    2000-04-20

    (251 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - For Irrigation of Medical Device Only . - Not for Injection or Flushing of Skin Tissues .
    Device Description
    Not Found
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    K Number
    K993119
    Device Name
    STERILE HYDROGEL
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1999-11-23

    (64 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.
    Device Description
    Sterile Hydrogel
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    K Number
    K990332
    Device Name
    DUMEX IODOFORM PACKING STRIP
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1999-04-14

    (70 days)

    Product Code
    FRO, MXI
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN
    Device Description
    Not Found
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    K Number
    K980779
    Device Name
    THALAFIX NATURAL SEA SALT DRESSING
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-06-26

    (116 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
    Device Description
    The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt.
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    K Number
    K980861
    Device Name
    DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-05-20

    (76 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydrogel dressing is intended for use to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment around the wound. The dressing is appropriate applied to the following indications: minor cuts, minor lacerations. Under the guidance of a health professional the hydrogel dressing is also indicated for surgical incisions and excisions, venous stasis ulcers and decubitus ulcers.
    Device Description
    Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel
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    K Number
    K980863
    Device Name
    DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-05-11

    (67 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Woven dressing impregnated with Sodium Chloride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor burns and minor lacerations. Under the guidance of a heatth care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
    Device Description
    Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride
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    K Number
    K980777
    Device Name
    DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-05-04

    (63 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will Sur that is mondou for act on moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the dressing is appropriate would offications will our cuts, minor burns and minor lacerations. Under the guidance for the following multions: himor outs, rather attern Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
    Device Description
    The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt.
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    K Number
    K980791
    Device Name
    DUMEX PAK-ITS WOVEN RIBBON PACKING
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1998-04-29

    (58 days)

    Product Code
    EFQ, EFO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.
    Device Description
    Not Found
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    K Number
    K960815
    Device Name
    DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
    Manufacturer
    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
    Date Cleared
    1996-04-29

    (61 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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