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 Class Implantable

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OCS Wireless Monitor, Universal
TRANSMEDICS, INC.
2450
In Commercial Distribution

  • B00939301 ()
  • B00939270 ()

  • Height: 3.5 Inch
  • Width: 8.5 Inch
  • Length: 9.5 Inch
2450

  • Donor-organ preservation/transport system control unit
OCS Wireless Monitor, Heart
TRANSMEDICS, INC.
1410
In Commercial Distribution

  • B00913390 ()
  • B00926311 ()

  • Length: 9.5 Inch
  • Width: 8.5 Inch
  • Height: 3.5 Inch
1410

  • Donor-organ preservation/transport system control unit
COVER 5441 DISPOSABLE GLBL 3PK PACK
MEDTRONIC, INC.
5441
Not in Commercial Distribution

  • 00613994521781 ()


  • External pacemaker cover
COVER 5441 DISPOSABLE EPG 3PK 16L
MEDTRONIC, INC.
5441
Not in Commercial Distribution

  • 20613994300083 ()
  • 00613994300089 ()


  • External pacemaker cover
Remote Control Panel Refurbished
BOSTON SCIENTIFIC CORPORATION
M00421880R0
Not in Commercial Distribution

  • 08714729790006 ()
M00421880R0

  • Percutaneous radio-frequency ablation system generator
MMR IHC Panel Antibody
Ventana Medical Systems, Inc.
790-5091
In Commercial Distribution

  • 07613336100561 ()
07862237001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MLH1 protein IVD, antibody
A stationary assembly of mains electricity (AC-powered) devices intended to produce two or three-dimensional (3-D) diagnostic digital x-ray images of a patient’s breast using cone beam computed tomography (CBCT); it may be intended to assist a breast biopsy procedure by providing 3-D localization and guidance. It consists of an x-ray source assembly and flat panel X-ray detector (gantry), high-frequency generator, and operating console with reconstruction software; it typically includes a patient table/platform with a hole through which the breast is inserted and scanned.
KONING CORPORATION
CBCT 1000
In Commercial Distribution

  • 19764496368300 ()
CBCT 1000

  • Cone beam computed tomography system, mammographic
For use the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5094
In Commercial Distribution

  • 07613336100592 ()
07862261001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
For use with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5092
In Commercial Distribution

  • 07613336100578 ()
07862245001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH6 antigen IVD, antibody
ONC UNIV DX RNA/DNA PANEL IVD
LIFE TECHNOLOGIES CORPORATION
A32441
Not in Commercial Distribution

  • 10190302006385 ()
  • 80190302006384 ()


  • Multiple tissue-associated protein/tumour marker IVD, reagent
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