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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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This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
In Commercial Distribution

10132914

  • Dental digital imaging sensor, intraoral
This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
Not in Commercial Distribution

  • EKAV101329140 ()
10132914

  • Dental digital imaging sensor, intraoral
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910110A
Not in Commercial Distribution

  • 30381780023719 ()
  • 10381780023715 ()
  • M272910110A1 ()

  • Cylinder 75ml, Drainage Bag 500ml
910110A

  • Cerebrospinal fluid external drainage kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910109
Not in Commercial Distribution

  • M2729101091 ()
  • 10381780034117 ()

  • Cylinder 75ml, Drainage Bag 500ml


  • Cerebrospinal fluid external drainage kit
Mixing Wells, 4-Well, Assorted Colors
PLASDENT CORPORATION
900MW-4(A)
In Commercial Distribution

  • D832900MW4A0 ()
  • D832900MW4A1 ()
900MW-4(A)

  • Dental material mixing surface, chairside, single-use
Mixing Wells, 2-Well, Assorted Colors
PLASDENT CORPORATION
900MW-2(A)
In Commercial Distribution

  • D832900MW2A0 ()
  • D832900MW2A1 ()
900MW-2(A)

  • Dental material mixing surface, chairside, single-use
Tinted Powder
JBC and Company
DPF/A
In Commercial Distribution

  • D851DPFA0 ()
DPF/A

  • Dental appliance fabrication material, resin
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
ACCURAY INCORPORATED
1048968
In Commercial Distribution

  • M65810489680 ()
N/A

  • Linear accelerator system
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.3
In Commercial Distribution

  • B816VNC2P30 ()
N/A

  • CT system application software
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