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510(k) Data Aggregation

    K Number
    K981441
    Device Name
    HEART CATH TRAY, STERILE, DISPOSABLE
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1998-07-10

    (80 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..
    Device Description
    Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..
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    K Number
    K974238
    Device Name
    DENTAL TRAY, STERILE, DISPOSABLE
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1998-02-04

    (84 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
    Device Description
    Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
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    K Number
    K974286
    Device Name
    CIRCUMCISION TRAY, CAT. NO. 70340
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1997-12-12

    (28 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..
    Device Description
    Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel.
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    K Number
    K972160
    Device Name
    CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1997-08-01

    (53 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration. The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.
    Device Description
    CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum. The CRP-LEX method is by latex slide agglutination.
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    K Number
    K970722
    Device Name
    EYE TRAY
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1997-03-31

    (32 days)

    Product Code
    KKX, HNM, HNN, HOY
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K965201
    Device Name
    O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1997-02-14

    (50 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964921
    Device Name
    BASIC BIOPSY TRAY. DISPOSABLE, STERILE
    Manufacturer
    TRINITY LABORATORIES, INC.
    Date Cleared
    1997-01-22

    (44 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY LABORATORIES, INC.

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

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