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 xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I027C0231
In Commercial Distribution

  • 00840487100141 ()
I027C0231

  • Cystic fibrosis IVD, kit, multiplex
No Description
GLOBAL SURGICAL CORPORATION
M 517HD1080V2-725I
In Commercial Distribution

  • 00810040255397 ()


  • General-purpose surgical microscope
BiLumix Shadowless Headlamp V2 Package includes - Headlamp - 2 Rechargable Batteries - 1 Charger - Attachable Light Source Cap (transparent, daylight and warm) - Headlight Bag, 1.5x Loupe
Hayden Medical, Inc.
BiLumixHLP-V2
In Commercial Distribution

  • 00840319715390 ()
BiLumixHLP-V2

  • Head-worn lamp
Sterile needle guide (barrel inserts only) for use with Siemens 4V2, 5C2, 6L3, 8L5, C3, C5, C366, C544, L5, L7, L582, V2 and V4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-062
In Commercial Distribution

  • 00841436104821 ()
  • 10841436104828 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-062

  • Needle guide, single-use
Sterile needle guide with (5 x 30cm) latex cover for use with Siemens 4V2, V4, V2, L5, L7, C5, C544, 8L5, 6L3 and 5C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-058
In Commercial Distribution

  • 00841436104807 ()
  • 10841436104804 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-058

  • Needle guide, single-use
MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
PERSPECTUM LTD
2.0.0
In Commercial Distribution

  • B554MRCP2000 ()


  • Radiology DICOM image processing application software
single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares
Steripack (usa) Limited LLC
60652
In Commercial Distribution

  • 00850027193182 ()
  • 00850027193397 ()
  • 00850027193366 ()


  • General-purpose absorbent tip applicator/swab, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1634
In Commercial Distribution

  • 09348215127602 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1628
In Commercial Distribution

  • 09348215127596 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1030-R
In Commercial Distribution

  • 00844685004706 ()
BRT-1030-R

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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