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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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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
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
No Description
Wuxi Wemade Healthcare Products Co., Ltd.
5CM X 450CM
In Commercial Distribution

  • 06938799200131 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE X Lite
In Commercial Distribution

  • 06903053003919 ()


  • General-purpose ultrasound imaging system
No Description
Foosin Medical Supplies Inc., Ltd.
A3-45 x 6
In Commercial Distribution

  • 06941813626800 ()
  • 06941813621805 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
No Description
Foosin Medical Supplies Inc., Ltd.
A4-45 x 6
In Commercial Distribution

  • 06941813626794 ()
  • 06941813621799 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
.5 x 500
In Commercial Distribution

  • 00660483130597 ()
1305

  • Medical device cleaning agent
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
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mm x 60mm
In Commercial Distribution

  • 00860005367542 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing
Mebo Life Science Inc.
60mm x 120mm
In Commercial Distribution

  • 00860005367535 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 14cm
Not in Commercial Distribution

  • 00851571007505 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 10.3 French
120010-14

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 12cm
Not in Commercial Distribution

  • 00851571007499 ()

  • Length: 12 Centimeter
  • Catheter Gauge: 10.3 French
120010-12

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 10cm
Not in Commercial Distribution

  • 00851571007482 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 10.3 French
120010-10

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 28cm
Not in Commercial Distribution

  • 00851571007284 ()

  • Catheter Gauge: 10.3 French
  • Length: 28 Centimeter
100010-28

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 26cm
Not in Commercial Distribution

  • 00851571007260 ()

  • Catheter Gauge: 10.3 French
  • Length: 26 Centimeter
100010-26

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 24cm
Not in Commercial Distribution

  • 00851571007246 ()

  • Catheter Gauge: 10.3 French
  • Length: 24 Centimeter
100010-24

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 22cm
Not in Commercial Distribution

  • 00851571007222 ()

  • Catheter Gauge: 10.3 French
  • Length: 22 Centimeter
100010-22

  • Polymeric ureteral stent
No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 20cm
Not in Commercial Distribution

  • 00851571007208 ()

  • Catheter Gauge: 10.3 French
  • Length: 20 Centimeter
100010-20

  • Polymeric ureteral stent
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