Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Mars1417XF-GSI Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1417XF-GSI
In Commercial Distribution

  • 06972093830014 ()


  • Indirect flat panel x-ray detector
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH VALVE
Arjohuntleigh AB
BCA1224-04
In Commercial Distribution

  • 05055982707954 ()
BCA1224-04

  • Shower unit
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH TANK
Arjohuntleigh AB
BCA1214-04
In Commercial Distribution

  • 05055982707916 ()
BCA1214-04

  • Shower unit
A wound cover extension panel for oversized legs that aids in the extension of the exucare which wraps around the leg which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC5051
In Commercial Distribution

  • 00856525007969 ()
ECX

  • First aid absorbent pad/bandage
The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0025
In Commercial Distribution

  • EABA40000251 ()
  • EABA40000250 ()
400-0025

  • Glucose/ketone/lipid profile IVD, reagent
The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0022
In Commercial Distribution

  • EABA40000221 ()
  • EABA40000220 ()
400-0022

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
No Description
DIASORIN MOLECULAR LLC
EL0950
In Commercial Distribution

  • 10816101022202 ()
EL0950

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520051 ()
NFPMD4335

  • Computed radiography digital imaging scanner
ACCESSORY OF Maestro Control Panel is a physical keyboard to be used to control Inventis audiometers, through Maestro software while performing audiometric exams.
INVENTIS SRL
MAESTRO CONTROL PANEL
In Commercial Distribution

  • 08054187380914 ()
12080

  • Tone audiometer
No Description
Aktina Corp.
51-225
In Commercial Distribution

  • B365512250 ()


  • Indexed-immobilization patient positioning system
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-II / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-01A
In Commercial Distribution

  • 00817830022924 ()

  • Length: 75 Millimeter
07RD-7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-II
RAPID DIAGNOSTICS INC
07RD-7061A
In Commercial Distribution

  • 00817830022917 ()

  • Length: 75 Millimeter
07RD-7061A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / EDDP / OPI-II / OXY / CREA
RAPID DIAGNOSTICS INC
07RD-7070-21
In Commercial Distribution

  • 00817830022887 ()

  • Length: 75 Millimeter
07RD-7070-21

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7072-10
In Commercial Distribution

  • 00817830022870 ()

  • Length: 75 Millimeter
07RD-7072-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / EDDP / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7145-03
In Commercial Distribution

  • 00817830022856 ()

  • Length: 75 Millimeter
07RD-7145-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
O7RD-7070-18
In Commercial Distribution

  • 00817830022849 ()

  • Length: 75 Millimeter
O7RD-7070-18

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7070-13
In Commercial Distribution

  • 00817830022832 ()

  • Length: 75 Millimeter
07RD-7070-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-08
In Commercial Distribution

  • 00817830022801 ()

  • Length: 75 Millimeter
07RD-7073-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution

  • 00817830022795 ()

  • Length: 75 Millimeter
07RD-7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7065-40
In Commercial Distribution

  • 00817830022788 ()

  • Length: 75 Millimeter
07RD-7065-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-09
In Commercial Distribution

  • 00817830022764 ()

  • Length: 75 Millimeter
07RD-7073-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7063-28
In Commercial Distribution

  • 00817830022733 ()

  • Length: 75 Millimeter
07RD-7063-28

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution

  • 00817830022726 ()

  • Length: 75 Millimeter
07RD-7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-11
In Commercial Distribution

  • 00817830022696 ()

  • Length: 75 Millimeter
07RD-7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pregnancy Panel Insert - 0.5mm Regular Lead
Shielding International Inc.
PPIRL
In Commercial Distribution

  • G031PPIRL0 ()


  • Radiation shielding apron
No Description
MAZOR ROBOTICS LTD
MAS1891-06S
In Commercial Distribution

  • 07290115751581 ()


  • Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
MAS1891-04
Not in Commercial Distribution

  • 07290109182063 ()
MAS1891-04S

  • Stereotactic surgery system probe, reusable
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520044 ()
NF3024C00

  • Computed radiography digital imaging scanner
AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23534
In Commercial Distribution

  • 15099590225735 ()
B23534

  • Multiple CD cell marker IVD, antibody
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