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The Lateral Access Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac Lateral Access BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle. During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow). An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed. The device is also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.

The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.

The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

The Ranfac Bone Marrow Biopsy Needles subject of this premarket notification (RTN-114, RTN-116, RTN-84, RTN-86, RTN-114-T, RTN 116-T, RTN-84-T, RTN-86-T, RJN -114, RJN -116, RJN-84, RJN-86) are manual, sterile disposable needles intended for the purpose of harvesting bone marrow specimens. The device is comprised of an outer cannula with handle and an inner stylet. The cannula has graduated etched markings spaced in 1 cm intervals. The product is provided with a probe guide and marked probe to assist with the extraction of the bone marrow specimen from the needle. The probe guide facilitates the insertion of the marked probe through the distal end of the needle. The marked probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. Specific models of the Ranfac Bone Marrow Biopsy Needles are also provided with a stainless steel marrow extraction cannula (either Canoe or Tweezer design) which fit inside the needle to facilitate capture and retrieval of bone marrow samples. The specimen is contained within the extraction cannula during withdrawal from the needle. The Ranfac Bone Marrow Biopsy Needles are provided with a luer cap to prevent back flow of blood during needle insertion and product with the optional extraction cannula are provided with two needle vices to cap the needle and stylet tip prior to disposal.

The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.

The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively).