March Device Description for Marrow Cellution Bone Marrow Aspiration Needle
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- Eustace Lawrence
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1 March 2017 Device Description for Marrow Cellution Bone Marrow Aspiration Needle The Marrow Cellution Bone Marrow Aspiration Needle is designed to allow for aspiration of bone marrow or autologous blood. This is accomplished by aspirating from the sides of the cannula only. To facilitate this we have added an additional cannula which replaces the blunt stylet once the desired location for aspiration has been achieved. The Adjustable Guide will be placed at the surface of the patient. After the Aspirator Cannula is attached to the Access Needle Handle by means of standard luer lock adapters, a standard piston syringe is attached to the Aspirator Cannula and aspiration commences. Aspiration continues in this manner until the desired amount of aspirate is achieved. Intended Use Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. Indications The indication for use for the Marrow Cellution Bone Marrow Aspiration Needle is Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. Instructions for Use Please refer to the Instructions for Use at the end of this Description. Contraindications Use only for bone marrow or autologous blood aspiration as determined by a licensed physician. The device is intended to be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of bone marrow aspiration. The procedure should be performed on patients that are suitable for such procedure only.
2 Warnings For single patient use only. The design of this device may not perform as intended by the manufacturer if it is re-used. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device. Precautions After use, this product may be a potential biohazard. Handle in a manner, which will prevent accidental puncture. Dispose of in accordance with applicable laws and regulations. Carefully place the used needle in a sharps biohazard container after the procedure is completed. Potential Adverse Effects While adverse effects are rare, they could include Bruising and discomfort at the biopsy site Prolonged bleeding from the biopsy site Infection near the biopsy site Alternative Therapy t applicable
3 Materials List of materials of the medical device making either direct or indirect contact with a human body Product: MC-RAN-11C and MC-RAN-11CSTS Component Description Materials Patient Contacting MC-RAN-11C or MC-RAN-11CSTS Stainless Steel tubing and wire. Aspiration Cannula Stainless Steel tubing. Stylet, Molded, Blunt Syringe, 10ml Luer Lock (BD) Needle Guards Polypropylene Body & Plunger with Elastomer Seal High & Low Density Polyethylene Product: MC-RAN-13C and MC-RAN-13CSTS Component Description Materials Patient Contacting MC-RAN-13C or MC-RAN-13CSTS Stainless Steel tubing and wire. Aspiration Cannula Stainless Steel tubing. Stylet, Molded, Blunt Syringe, 10ml Luer Lock (BD) Needle Guards Polypropylene Body & Plunger with Elastomer Seal High & Low Density Polyethylene
4 Product: MC-RAN-8C and MC-RAN-8CSTS Component Description Materials Patient Contacting MC-RAN-11C or MC-RAN-11CSTS Stainless Steel tubing and wire. Bone Marrow Biopsy Needle Stainless Steel tubing and 8Ga. x 10cm or 8Ga. x 15cm wire. Stylet, Molded, Blunt Syringe, 10ml Luer Lock (BD) Polypropylene Body & Plunger with Elastomer Seal Needle Guards High & Low Density Polyethylene Probe Probe Guide Aspiration Cannula Stainless Steel tubing. Bone Marrow Biopsy Cannula Stainless Steel tubing. Product: MC-RAN-13A and MC-RAN-13ASTS Component Description Materials Patient Contacting MC-RAN-13C or MC-RAN-13CSTS Stainless Steel tubing and wire. Bone Marrow Biopsy Needle Stainless Steel tubing and 8Ga. x 10cm or 8Ga. x 15cm wire. Stylet, Molded, Blunt Syringe, 10ml Luer Lock (BD) Needle Guards Polypropylene Body & Plunger with Elastomer Seal High & Low Density Polyethylene
5 Component Description Materials Patient Contacting Probe Probe Guide Aspiration Cannula Stainless Steel tubing. Bone Marrow Biopsy Cannula Stainless Steel tubing. i- Complete chemical, biological and physical characterization of the materials of the medical device making either direct or indirect contact with a human body For chemical and physical characteristics please see Certificates of Conformity by PT# in Appendix 6 Component Description MC-RAN-11C & MC-RAN-11CSTS Product MC-RAN-11C & MC-RAN-11CSTS Materials St. St. Tube 11Ga. RW Pt# P St. St. Wire.0905 Dia. Pt# P Needle Guard, LDPE 5.00 Pt# P Stylet, Molded, Blunt St. St. Wire.0905 Dia. Pt# P Aspiration Cannula St. St. Tube 14Ga. RW Pt# P Luer Locking Ring, Polycarbonate Pt# P Syringe, 10ml Luer Lock (BD) Polypropylene Body & Plunger with Elastomer Seal Pt# P
6 Component Description MC-RAN-13C & MC-RAN-13CSTS Product MC-RAN-13C & MC-RAN-13CSTS Materials St. St. Tube 13Ga. HW Pt# P St. St. Wire.0620 Dia. Pt# P Needle Guard, LDPE 5.00 Pt# P Stylet, Molded, Blunt St. St. Wire.0620 Dia. Pt# P Aspiration Cannula St. St. Tube 17Ga. RW Pt# P Luer Locking Ring, Polycarbonate Pt# P Syringe, 10ml Luer Lock (BD) Polypropylene Body & Plunger with Elastomer Seal Pt# P
7 Component Description MC-RAN-11C & MC-RAN-11CSTS Product MC-RAN-8C & MC-RAN-8CSTS Materials St. St. Tube 11Ga. RW Pt# P St. St. Wire.0905 Dia. Pt# P Needle Guard, LDPE 5.00 Pt# P Stylet, Molded, Blunt St. St. Wire.0905 Dia. Pt# P Aspiration Cannula St. St. Tube 14Ga. RW Pt# P Luer Locking Ring, Polycarbonate Pt# P Bone Marrow Biopsy Needle 8Ga. x 10cm(C) & 8Ga. x 15cm (CSTS) St. St. Tube 8Ga. RW Pt# P St. St. Wire.1050 Dia. Pt# P ABS, Green, Cycolac HMG47-MD Pt# P ABS, White, Cycolac HMG47-MD Pt# P Needle Guard, LDPE 5.00 Pt# P (C) Needle Guard, LDPE Pt# P(CSTS) Syringe, 10ml Luer Lock (BD) Polypropylene Body & Plunger with Elastomer Seal Pt# P Probe St. St. Wire.0905 Dia. Pt# P Probe Guide ABS, Gray, Cycolac HMG47-MD Pt# P Bone Marrow Biopsy Cannula St. St. Tube 11Ga. UTW Pt# P Needle Guard, LDPE 6.5 Pt# P (C) Needle Guard, LDPE 8.5 Pt# P (CSTS)
8 Component Description MC-RAN-13C & MC-RAN-13CSTS Product MC-RAN-13A & MC-RAN-13ASTS Materials St. St. Tube 13Ga. HW Pt# P St. St. Wire.0620 Dia. Pt# P Needle Guard, LDPE 5.00 Pt# P Stylet, Molded, Blunt St. St. Wire.0905 Dia. Pt# P Aspiration Cannula St. St. Tube 17Ga. RW Pt# P Luer Locking Ring, Polycarbonate Pt# P Bone Marrow Biopsy Needle 8Ga. x 10cm(C) & 8Ga. x 15cm (CSTS) St. St. Tube 8Ga. RW Pt# P St. St. Wire.1050 Dia. Pt# P ABS, Green, Cycolac HMG47-MD Pt# P ABS, White, Cycolac HMG47-MD Pt# P Needle Guard, LDPE 5.00 Pt# P (C) Needle Guard, LDPE Pt# P(CSTS) Syringe, 10ml Luer Lock (BD) Polypropylene Body & Plunger with Elastomer Seal Pt# P Probe St. St. Wire.0905 Dia. Pt# P Probe Guide ABS, Gray, Cycolac HMG47-MD Pt# P Bone Marrow Biopsy Cannula St. St. Tube 11Ga. UTW Pt# P Needle Guard, LDPE 6.5 Pt# P (C) Needle Guard, LDPE 8.5 Pt# P (CSTS)
9 Other relevant specifications For MC-RAN-11C, MC-RAN-11CSTS, MC-RAN-13C & MC-RAN-13CSTS The Marrow Cellution Bone Marrow Aspiration Needle functions by attaching a syringe to the needle after placement and aspirating bone marrow or autologous blood. The key function of the needle is that the holes in the aspiration cannula are on the side so they aspirate from the side rather than the end of the cannula. This affords a sample to be taken and then by rotating the handles in relation to the adjustable guide, withdrawing the needle a small distance and then taking a sample from a different area. For MC-RAN-8C, MC-RAN-8CSTS, MC-RAN-13A & MC-RAN-13ASTS These needles feature the same components as the previously described needles with the addition of a Bone Marrow Biopsy Needle & Cannula with Probe and Probe Guide to allow for the option of a traditional Bone Marrow Biopsy if desired. Other Descriptive Information The novel feature of the MC-RAN is the ability to aspirate from the side of the cannula and retract the cannula accurately to present new areas for aspiration.
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