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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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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
NEEDLE, RAN-1115N5B F/G, STERILE, CE P/N: 74354-01M
RANFAC CORP.
11Ga x 15CM
In Commercial Distribution

  • 00857878007972 ()
  • 10857878007979 ()
  • 20857878007976 ()

  • Needle Gauge: 11 Gauge
  • Length: 15 Centimeter
RAN-1115N5B

  • Bone access cannula
RAN-11, F/G, STERILE CE MARKED P/N: 74062-02M
RANFAC CORP.
11Ga X 11cm
In Commercial Distribution

  • 00857878007873 ()
  • 10857878007870 ()
  • 20857878007877 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
RAN-11

  • Bone access cannula
Disc Cath PN 76102-01M
RANFAC CORP.
17GA X 6"
In Commercial Distribution

  • 10857878007832 ()
  • 00857878007835 ()
  • 20857878007839 ()

  • Length: 6 Inch
  • Needle Gauge: 17 Gauge
Disc Cath

  • Spinal needle, single-use
MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 10CM RJN-810 PN 74340-03M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 00857878007828 ()
  • 10857878007825 ()
  • 20857878007822 ()

  • Needle Gauge: 11 Gauge
  • Length: 11 Centimeter
  • Needle Gauge: 8 Gauge
  • Length: 15 Centimeter
BM-MXC-3

  • Bone access cannula
RANFAC ASPIRATION NEEDLE RAN-1311H-OT PN 74333-01M
RANFAC CORP.
13Ga X 11CM
In Commercial Distribution

  • 00857878007798 ()
  • 10857878007795 ()
  • 20857878007792 ()

  • Needle Gauge: 13 Gauge
  • Length: 11 Centimeter
RAN-1311H-OT

  • Bone access cannula
RAN-8N, F/G, STERILE, RANFAC P/N 74091-01M
RANFAC CORP.
11CM X 8GA
In Commercial Distribution

  • 20857878007785 ()
  • 10857878007788 ()
  • 00857878007781 ()

  • Needle Gauge: 8 Gauge
  • Length: 11 Centimeter
RAN-8N

  • Bone access cannula
RAN-8, SF, F/G, STERILE, RANFAC P/N 74171-11M
RANFAC CORP.
8GA X 11CM
In Commercial Distribution

  • 20857878007778 ()
  • 10857878007771 ()
  • 00857878007774 ()

  • Needle Gauge: 8 Gauge
  • Length: 11 Centimeter
RAN-8

  • Bone access cannula
RAN-8-301, F/G, STERILE P/N 74150-01M
RANFAC CORP.
8GA X 11CM
In Commercial Distribution

  • 00857878007750 ()
  • 10857878007757 ()
  • 20857878007754 ()

  • Needle Gauge: 8 Gauge
  • Length: 11 Centimeter
RAN-8-301

  • Bone access cannula
RBN-116S P/N 74093-02M
RANFAC CORP.
11GA X 6"
In Commercial Distribution

  • 20857878007679 ()
  • 10857878007672 ()
  • 00857878007675 ()

  • Needle Gauge: 11 Gauge
  • Length: 6 Inch
RBN-116S

  • Bone marrow biopsy needle, single-use
Cartilage Biopsy Needle, CBN-114 PN 74328-01M Customer #: 0013091
RANFAC CORP.
11GA X 4"
In Commercial Distribution

  • 20857878007648 ()
  • 10857878007641 ()
  • 00857878007644 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
CBN-114

  • Bone marrow biopsy needle, single-use
RAN-823-CT, F/G, Sterile Part Number: 74315-02M
RANFAC CORP.
8GA X 23CM
In Commercial Distribution

  • 20857878007518 ()
  • 10857878007511 ()
  • 00857878007514 ()

  • Needle Gauge: 8 Gauge
  • Length: 23 Centimeter
RAN-823-CT

  • Bone access cannula
RAN-823-OT, F/G, Sterile Part Number 74315-01M
RANFAC CORP.
8GA X 23CM
In Commercial Distribution

  • 20857878007501 ()
  • 10857878007504 ()
  • 00857878007507 ()

  • Needle Gauge: 8 Gauge
  • Length: 23 Centimeter
RAN-823-OT

  • Bone access cannula
MC-RAN-11CSTS MAXX CELL WITH PREPARATION ACCESSORIES PN 74317-02M Customer# 0018407
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 00857878007453 ()
  • 10857878007450 ()
  • 20857878007457 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
MXC-2

  • Bone marrow biopsy procedure kit
Maxx-Cell Bone Marrow Aspiration Kit Customer # 0018407 PN 74317-07M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 20857878007358 ()
  • 10857878007351 ()
  • 00857878007354 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
MXC-1

  • Bone access cannula
MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 10857878007313 ()
  • 00857878007316 ()
  • 20857878007310 ()

  • Needle Gauge: 11 Gauge
  • Length: 11 Centimeter
  • Needle Gauge: 8 Gauge
  • Length: 15 Centimeter
MXC-3

  • Bone access cannula
Ranfac Aspiration Needle, 15GA X 4", Sterile, F/G P/N 74118-01M
RANFAC CORP.
15GA X 4"
In Commercial Distribution

  • 00857878007286 ()
  • 10857878007283 ()

  • Length: 4 Inch
  • Needle Gauge: 15 Gauge
RAN-154-1

  • Bone access cannula
RAN-825HRT CUSTOMER #514001-040 PN 74216-25M
RANFAC CORP.
8GA x 250mm
In Commercial Distribution

  • 10857878007184 ()
  • 00857878007187 ()

  • Length: 250 Millimeter
  • Needle Gauge: 8 Gauge
RAN-825HRT

  • Bone access cannula
RTN-86-T, F/G, 74212-01M
RANFAC CORP.
8GA x 6
In Commercial Distribution

  • 20857878007174 ()
  • 10857878007177 ()
  • 00857878007170 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
RTN-86-T

  • Bone marrow biopsy needle, single-use
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
RAN-16(2.8)N5T, F/G PN 74048-03M
RANFAC CORP.
16GA x 2.8"
In Commercial Distribution

  • 20858690006895 ()
  • 10858690006898 ()
  • 00858690006891 ()

  • Length: 2.8 Inch
  • Needle Gauge: 16 Gauge
RAN-16(2.8)N5T

  • Bone access cannula
MC-RAN 13A, RJN-84 PN 74293-01M
RANFAC CORP.
13Gauge X 9CM
In Commercial Distribution

  • 20858690006703 ()
  • 10858690006706 ()
  • 00858690006709 ()

  • Length: 9 Centimeter
  • Needle Gauge: 13 Gauge
  • Needle Gauge: 8 Gauge
  • Length: 10 Centimeter
MC-RAN 13A

  • Bone access cannula
RBN-86 P/N 74225-01M
RANFAC CORP.
8GA X 6"
In Commercial Distribution

  • 00858690006365 ()
  • 10858690006362 ()
  • 20858690006369 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
RBN-86

  • Bone marrow biopsy needle, single-use
Ranfac Aspiration Needle, 11GA X 150mm RAN-1115N5T, Sterile, F/G P/N 74181-15M
RANFAC CORP.
11GA X 150mmN5T
In Commercial Distribution

  • 20858690006352 ()
  • 10858690006355 ()
  • 00858690006358 ()

  • Length: 150 Millimeter
  • Needle Gauge: 11 Gauge
RAN-1115N5T

  • Bone access cannula
Disc Cath P/N: 76102-02M
RANFAC CORP.
17GA X 6"
In Commercial Distribution

  • 10858690006249 ()
  • 00858690006242 ()
  • 20858690006246 ()

  • Length: 6 Inch
  • Needle Gauge: 17 Gauge
Disc Cath

  • Spinal needle, single-use
MC-RAN-11CSTS MAXX-REGEN Customer # 0018407 PN 74292-02M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 00858690006228 ()
  • 10858690006225 ()
  • 20858690006222 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
RB-REG-2

  • Bone access cannula
MC-RAN-11C-MAXX REGEN PN 74292-01M Customer# 0018407
RANFAC CORP.
11GA X 9CM
In Commercial Distribution

  • 00858690006211 ()
  • 10858690006218 ()
  • 20858690006215 ()

  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
RB-REG-1

  • Bone access cannula
RBN-114S P/N 74092-01M
RANFAC CORP.
11GA X 4"
In Commercial Distribution

  • 20858690006048 ()
  • 10858690006041 ()
  • 00858690006044 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114S

  • Bone marrow biopsy needle, single-use
Patient Armor Sterilization Pouches 2.75 x 10" - 200/Bx
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
2.75" x 10"
In Commercial Distribution

  • 00858653006005 ()
AMH-210

  • Sterilization packaging, single-use
Pouch, PW XL 3FR 6cm (US) for Kit (40351)
ACCESS SCIENTIFIC, LLC
3Fr x 6cm
In Commercial Distribution

  • 00859821006810 ()

  • Catheter Gauge: 3 French
  • Catheter Working Length: 6 Centimeter
40351

  • Vascular catheter introduction set, nonimplantable
The CVC WAND Safety Introducer with Valved Peelable Sheath
ACCESS SCIENTIFIC, LLC
7Fr X 6cm
In Commercial Distribution

  • 20859821006715 ()
  • 10859821006718 ()
  • 00859821006711 ()

  • Catheter Length: 6 Centimeter
  • Catheter Gauge: 7 French
93102

  • Vascular catheter introduction set, nonimplantable
The CVC WAND Safety Introducer with Valved Peelable Sheath
ACCESS SCIENTIFIC, LLC
7Fr X 6cm
In Commercial Distribution

  • 20859821006708 ()
  • 10859821006701 ()
  • 00859821006704 ()

  • Catheter Length: 6 Centimeter
  • Catheter Gauge: 7 French
93001

  • Vascular catheter introduction set, nonimplantable
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