The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsedultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.

Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.

The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.

Barricaid® Annular Closure Device (ACD), 10mm width/size.

Barricaid® Annular Closure Device (ACD), 8mm width/size

Alignment and sizing trial (10mm size) used to support implantation of the Barricaid® ACD.

Alignment and sizing trial (8mm size) used to assist with implantation of the Barricaid® ACD.

Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the measurement of soft tissue defects.

Surgical mallet (slotted), for general use as well as specifically to support implantation of the Barricaid® Annular Closure Device (ACD).

Wedge to aid in retraction of the delivery tool following implantation of the Barricaid® Annular Closure Device (ACD). Reusable wedge designed to help pull back the strike cap following full Barricaid deployment.

Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the measurement of soft tissue defects.

Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the measurement of soft tissue defects.

Reusable extractor designed to facilitate Barricaid ACD removal, should it be necessary.

Surgical hammer, for general use as well as specifically to support implantation of the Barricaid Anular Closure Device (ACD).

Reusable impactor designed to further advance the Barricaid Anular Closure Device (ACD) anchor into the vertebral body, if during the implantation the satisfactory depth has not been achieved and the Barricaid delivery tool has already been removed.

Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). Note that the implant itself, as well as the delivery tool to which the implant is pre-loaded, are single-use sterile and supplied separately.

Empty tray to hold kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). This is an empty tray, instruments provided separately. Note that the implant itself, as well as the delivery tool to which the implant is pre-loaded, are single-use sterile and supplied separately.

Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). Note that the implant itself, as well as the delivery tool to which the implant is pre-loaded, are single-use sterile and supplied separately.

Sizing trial (10mm size) used to support implantation of the Barricaid ACD.

Sizing/alignment trial (8mm size) used to assist with implantation of the Barricaid ACD.

Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable wedge designed to help pull back the strike cap following full Barricaid deployment.

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-2000 / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC / PCP / OXY

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP/ BZD / COC / M-AMP / MTD / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / BUP / COC / M-AMP / MTD / OPI / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-2000 / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / MTD / M-AMP / OPI-2000 / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / MTD / OPI / OPI-2000 / OXY / PCP / THC

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.

Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC