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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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WASHER DISINFECTOR 46-5 S+NO D, S+NO D indicating single door machine without dryer. Cat no was 46-5-400. From March 2019 new cat no is 46-5-500.
Getinge Disinfection AB
46-5
In Commercial Distribution

  • 07340153700055 ()
46-5-500

  • Surgical utensil washer/disinfector
WASHER DISINFECTOR 46-4 D+NO D, D+NO D indicating double door machine without dryer. Cat no was 46-4-401. New cat no from March 2019 is 46-4-501.
Getinge Disinfection AB
46-4
In Commercial Distribution

  • 07340153700024 ()
46-4-501

  • Surgical utensil washer/disinfector
BL100 Single use Video Laryngoscope is a rigid laryngoscope used to examine and visualize a patient’s upper airway and aid in the placement of a tracheal tube.
Zhuhai Pusen Medical Technology Co, Ltd
BL100
In Commercial Distribution

  • 06971176280142 ()
  • 16971176280149 ()


  • Rigid intubation laryngoscope, single-use
ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped syringes during surgery. For single use only
ITL ASIA PACIFIC SDN. BHD.
A500102
In Commercial Distribution

  • 09555240401199 ()
  • 19555240401196 ()
A500102

  • Surgical instrument containment holder, single-use, non-sterile
The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9150ML
In Commercial Distribution

  • 00845533001618 ()
FA9150ML

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9150L
In Commercial Distribution

  • 00845533001601 ()
FA9150L

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9152
In Commercial Distribution

  • 00845533001595 ()
FA9152

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 7.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ7IMP
Not in Commercial Distribution

  • M268HITORQ7IMP1 ()
  • 10381780064558 ()
HITORQ7IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 4.0mm and 5.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ45IMP
Not in Commercial Distribution

  • M268HITORQ45IMP1 ()
  • 10381780064541 ()
HITORQ45IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 2.0mm and 3.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ23IMP
Not in Commercial Distribution

  • M268HITORQ23IMP1 ()
  • 10381780064534 ()
HITORQ23IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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