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510(k) Data Aggregation

    K Number
    K222481
    Device Name
    PuraStat
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2023-02-28

    (195 days)

    Product Code
    QAU, OAU
    Regulation Number
    878.4456
    Why did this record match?
    Applicant Name (Manufacturer) :

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.
    Device Description
    PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.
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    K Number
    K213552
    Device Name
    PuraStat-RM
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2022-04-01

    (144 days)

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

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
    Device Description
    PuraStat-RM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat-RM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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    K Number
    K210211
    Device Name
    PuraStat-OM
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2021-10-08

    (254 days)

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

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing. Manages pain of, for example: - All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa - Canker sores and cold sores - Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders - Soft tissue pain from orthodontics - Aphthous ulcers - Extraction site pain - Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)
    Device Description
    PuraStat-OM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. PuraStat-OM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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    K Number
    K210098
    Device Name
    PuraStat-GI
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2021-06-25

    (162 days)

    Product Code
    QAU
    Regulation Number
    878.4456
    Why did this record match?
    Applicant Name (Manufacturer) :

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat-GI is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding.
    Device Description
    PuraStat-GI is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat-GI is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.
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    K Number
    K193085
    Device Name
    PuraDERM Gel
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2020-05-11

    (188 days)

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

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.
    Device Description
    PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin. The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel. PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.
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    K Number
    K183015
    Device Name
    PuraSinus
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2019-04-12

    (163 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.
    Device Description
    PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue. PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.
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    K Number
    K143058
    Device Name
    PuraDerm Gel
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2015-02-13

    (112 days)

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

    3-D Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: PuraDerm is used for the management of minor cuts, minor abrasions, minor wounds and minor burns (1st degree burns). Rx: Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure ulcers, diabetic ulcers, and surgical wounds.
    Device Description
    PuraDerm™ Gel is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraDerm forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue. PuraDerm is completely non-animal and non-plant derived, and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraDerm can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.
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