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510(k) Data Aggregation
K Number
K231513Device Name
Oral Matrix
Manufacturer
Beijing Biosis Healing Biological Technology Co., Ltd.
Date Cleared
2024-02-16
(267 days)
Product Code
NPL
Regulation Number
872.3930Why 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
K203622Device Name
Medical Gloves
Manufacturer
Beijing Biosis Healing Biological Technology Co., Ltd.
Date Cleared
2021-08-20
(252 days)
Product Code
LZA
Regulation Number
880.6250Why 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
K201639Device 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
878.4750Why 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
K201641Device Name
Disposable Laparoscope Trocar
Manufacturer
Beijing Biosis Healing Biological Technology Co., Ltd.
Date Cleared
2020-08-06
(51 days)
Product Code
GCJ
Regulation Number
876.1500Why 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
K201243Device 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
876.1500Why 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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