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510(k) Data Aggregation

    K Number
    K231513
    Device Name
    Oral Matrix
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd.
    Date Cleared
    2024-02-16

    (267 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.
    Device Description
    The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6. The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below. | Model | Size (cm) | Tolerance | Thickness | |--------------------|-----------|-----------|-------------| | SIS-ORP-4L-1×1 | 1×1 | | | | SIS-ORP-4L-2×2 | 2×2 | | | | SIS-ORP-4L-2×3 | 2×3 | | | | SIS-ORP-4L-3×3 | 3×3 | | | | SIS-ORP-4L-4×3 | 4×3 | | | | SIS-ORP-4L-6×6 | 6×6 | | | | SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-4×4 | 4×4 | | | | SIS-ORP-4L-5×5 | 5×5 | | | | SIS-ORP-4L-6×8 | 6×8 | | | | SIS-ORP-4L-8×8 | 8×8 | | |
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    K Number
    K203622
    Device Name
    Medical Gloves
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd.
    Date Cleared
    2021-08-20

    (252 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.
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    K Number
    K201639
    Device Name
    Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd.
    Date Cleared
    2021-05-27

    (345 days)

    Product Code
    GDW, GAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease. The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue. The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
    Device Description
    Disposable Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five specifications. The staple is available in 4.5mm and 4.8mm two different heights. Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure. Disposable Hemorrhoidal Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded. Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure. The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.
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    K Number
    K202844
    Device Name
    Medical Surgical Gowns
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd
    Date Cleared
    2021-01-06

    (103 days)

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

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Surgical Gowns is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.
    Device Description
    The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.
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    K Number
    K202029
    Device Name
    Medical Surgical Mask
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd
    Date Cleared
    2020-12-16

    (147 days)

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

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
    Device Description
    The proposed device, Medical Surgical Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m2 PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and PU, and tie strings are made of Nylon. The nose clip which is made of Iron strip covered by polypropylene covering. The device is provided in sterile.
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    K Number
    K201641
    Device Name
    Disposable Laparoscope Trocar
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd.
    Date Cleared
    2020-08-06

    (51 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
    Device Description
    The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.
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    K Number
    K201243
    Device Name
    Disposable Specimen Retrieval Bag
    Manufacturer
    Beijing Biosis Healing Biological Technology Co., Ltd.
    Date Cleared
    2020-07-10

    (63 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Biosis Healing Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
    Device Description
    The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use
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