Nationwide Distribution --- including states of AK, GA, IL, and MA.
Descripción del producto
Barco Surgical Display, Model MDSC-2124 || The 24-inch MDSC-2124 is a near-patient surgical display that uses widescreen (16:10) LCD technology featuring full High Definition resolution (1920 x 1200). Featuring broad input connectivity, the MDSC-2124 offers a versatile display solution for HD endoscopy cameras, room and boom cameras, ultrasound, PACS and patient information.
Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
Descripción del producto
Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
SERIAL NUMBERS: 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 107, 1031, 1032, 1041, 1065, and 1071.
Clase de dispositivo
Not Classified
¿Implante?
No
Distribución
Devices were distributed Universities, Institute, and government consignees in CT, IL, MA, MD, OH, TN, TX, and UT. One unit was distributed to Germany.
Descripción del producto
Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. || The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. || The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".
Model Number : Examiner 3DX 6000 cabinet x-ray system
Clase de dispositivo
Not Classified
¿Implante?
No
Distribución
USA (nationwide) Distribution. Owned and operated by the U.S. Transportation Security Administration. Location of individual products is law enforcement sensitive. TSA HQ is located in Crystal City, Virginia.
Descripción del producto
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
Crimson Trace Corporation laser sights. || The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
Phoenix x/ray nanotom series. || Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
Part Number: 35-001466-032, Corresponding Unit Serial Numbers: 00001,00002, and 00003.
Clase de dispositivo
Not Classified
¿Implante?
No
Distribución
Worldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada.
Descripción del producto
LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defective type"A" fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Lockheed Martin Aculight, Bothell, WA, 98021. || Pulsed laser energy generator intended for use as an OEM component for the LiDAR/Rangefinding, Surveillance, Mapping, and Sensing.
Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
Clase de dispositivo
Not Classified
¿Implante?
No
Distribución
Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
Descripción del producto
Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
Descripción del producto
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
Descripción del producto
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.
Descripción del producto
ActCel || advanced bleeding control || Topical Hemostatic Dressing || 2in X 2in (5cm X 5cm) || 4in X 4in || Sterile Contents || Soluble Regenerated Cellulose || For Bleeding Control || For external topical and temporary use only || Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. || The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and United Kingdom.
Descripción del producto
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. || This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. || Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.