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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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RTN-114-T, F/G, 74213-01M
RANFAC CORP.
11GA X 4
In Commercial Distribution

  • 20857878007167 ()
  • 10857878007160 ()
  • 00857878007163 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RTN-114-T

  • Bone marrow biopsy needle, single-use
RTN-84-T, F/G, 74211-01M
RANFAC CORP.
8GA x 4
In Commercial Distribution

  • 20857878007150 ()
  • 10857878007153 ()
  • 00857878007156 ()

  • Length: 4 Inch
  • Needle Gauge: 8 Gauge
RTN-84-T

  • Bone marrow biopsy needle, single-use
RTN-116-T, F/G, P/N 74214-01M
RANFAC CORP.
11Ga x 6
In Commercial Distribution

  • 10857878007122 ()
  • 00857878007125 ()
  • 20857878007129 ()

  • Length: 6 Inch
  • Needle Gauge: 11 Gauge
RTN-116-T

  • Bone marrow biopsy needle, single-use
RAN-815VPH, 2X 30CC SYRINGE PN# 74267-01M
RANFAC CORP.
8GA x 15CM
In Commercial Distribution

  • 20857878007112 ()
  • 10857878007115 ()
  • 00857878007118 ()

  • Needle Gauge: 8 Gauge
  • Length: 15 Centimeter
RAN-815VPH

  • Bone access cannula
MC-RAN-13FAB, MC-RAN-13FA WITH RJN-810 AND ACCESSORIES
RANFAC CORP.
13Gauge X 5CM
In Commercial Distribution

  • 20857878007099 ()
  • 10857878007092 ()
  • 00857878007095 ()

  • Needle Gauge: 13 Gauge
  • Length: 5 Centimeter
  • Needle Gauge: 8 Gauge
  • Length: 10 Centimeter
MC-RAN-13FAB

  • Bone access cannula
Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM
RANFAC CORP.
13GA X 5CM
In Commercial Distribution

  • 20857878007082 ()
  • 10857878007085 ()
  • 00857878007088 ()

  • Length: 5 Centimeter
  • Needle Gauge: 13 Gauge
MC-RAN-13FA

  • Bone marrow biopsy procedure kit
RAN-86-14, PN# 74099-01M
RANFAC CORP.
8GA x 6"
In Commercial Distribution

  • 00857878007057 ()
  • 10857878007054 ()
  • 20857878007051 ()

  • Needle Gauge: 8 Gauge
  • Length: 6 Inch
RAN-86-14

  • Bone access cannula
MAXX-REGEN Bone Marrow Aspirate Kit w/ Bone Harvester 11GA X 11CM MC-RAN-11CSTS 8GA X 10CM RJN-810 Customer # 0018407 PN 74292-03M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 20857878007037 ()
  • 10857878007030 ()
  • 00857878007033 ()

  • Length: 10 Centimeter
  • Needle Gauge: 8 Gauge
  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
RB-REG-3

  • Bone access cannula
SUTURE GRASPER, 14GA #0013838 PN 76026-01M
RANFAC CORP.
15CM X 14GA
In Commercial Distribution

  • 20857878007006 ()
  • 10857878007009 ()
  • 00857878007002 ()

  • Needle Gauge: 14 Gauge
  • Length: 15 Centimeter
RSG-14-102

  • Suturing unit, single-use
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS. The software product integrates with the following components of the MPTS system: • X-ray generator & tube assembly • Amorphous silicon flat-panel detector • Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs. There are two defined methods of registration, 1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system. 2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution

  • 00866854000401 ()
n/a

  • CT system application software
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