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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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The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
SM9Z9481G
In Commercial Distribution

  • 00845533000543 ()
SM9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
9Z9481G
In Commercial Distribution

  • 00845533000529 ()
9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy.
NIDEK CO.,LTD.
YC-200
In Commercial Distribution

  • 04987669101452 ()


  • Ophthalmic solid-state laser system, photodisruption
SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. Smart MTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indrect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.
BioMTA
SmMTA-02
In Commercial Distribution

  • 08800027200030 ()


  • Endodontic filling/sealing material
The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.
ABAXIS, INC.
400-0034
In Commercial Distribution

  • EABA40000341 ()
  • EABA40000340 ()
400-0034

  • C-reactive protein (CRP) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Total creatine kinase (CK) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
22.5 cm - 9"
In Commercial Distribution

  • 08056459671249 ()
  • 18056459671246 ()

  • Length: 22.5 Centimeter
  • Length: 9 Inch
203.06.10.22US

  • Anaesthesia conduction catheterization kit
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
15 cm - 6"
In Commercial Distribution

  • 08056459671232 ()
  • 18056459671239 ()

  • Length: 15 Centimeter
  • Length: 6 Inch
203.06.10.15US

  • Anaesthesia conduction catheterization kit
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
7.5 cm - 3"
In Commercial Distribution

  • 08056459671225 ()
  • 18056459671222 ()

  • Length: 7.5 Centimeter
  • Length: 3 Inch
203.06.10.07US

  • Anaesthesia conduction catheterization kit
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
2.5 cm - 1"
In Commercial Distribution

  • 08056459671218 ()
  • 18056459671215 ()

  • Length: 2.5 Centimeter
  • Length: 1 Inch
203.06.10.02US

  • Anaesthesia conduction catheterization kit
A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
HOBBS MEDICAL, INC.
2182
In Commercial Distribution

  • M84981821 ()
  • M84921820 ()
2182

  • Irrigation catheter, single-lumen
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