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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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Change Healthcare Cardiology - 17540262090048

No Description
Change Healthcare Canada Company
14.3
In Commercial Distribution

  • 17540262090048 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090031

No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262090031 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090024

No Description
CHANGE HEALTHCARE ISRAEL LTD
14.1.1
In Commercial Distribution

  • 17540262090024 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090017

No Description
CHANGE HEALTHCARE ISRAEL LTD
14.1
In Commercial Distribution

  • 17540262090017 ()


  • Cardiology information system

Clear Guide SCENERGY TP - B201CGSCENERGYTP0

The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
CLEAR GUIDE MEDICAL, INC.
CGSCENERGYTP
In Commercial Distribution

  • B201CGSCENERGYTP0 ()
  • B201CGSCENERGYTP1 ()
CG-SCENERGY-TP

  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Clear Guide SCENERGY - B201CGSCENERGY0

No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software

CERVMAX® - 00650551004257

CTO Support Bars with Hardware (Qty 2) NO Vest or Collar
PMT CORPORATION
1625-2
In Commercial Distribution

  • 00650551004257 ()


  • Cervical spine collar, single-use

Orfit Industries - 05420028746721

LD Head Support - Model 2 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32415
In Commercial Distribution

  • 05420028746721 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028746714

LD Head Support - Model 1 With Lateral Neck Flaps – Other Hardware
Orfit Industries NV
32414
In Commercial Distribution

  • 05420028746714 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028746707

LD Head Support - Model 4 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32413
In Commercial Distribution

  • 05420028746707 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028746691

LD Head Support - Model 3 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32412
In Commercial Distribution

  • 05420028746691 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028746684

LD Head Support - Model 6 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32411
In Commercial Distribution

  • 05420028746684 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028746660

LD Head Support - Model 5 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32410
In Commercial Distribution

  • 05420028746660 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763551

RD Head Support - Model 2 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32423ZF-MD
In Commercial Distribution

  • 05420028763551 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763544

RD Head Support - Model 1 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32423-MD
In Commercial Distribution

  • 05420028763544 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763537

RD Head Support - Model 6 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422ZF-MD
In Commercial Distribution

  • 05420028763537 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763520

RD Head Support - Model 5 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422-MD
In Commercial Distribution

  • 05420028763520 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763513

RD Head Support - Model 4 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421ZF-MD
In Commercial Distribution

  • 05420028763513 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028763506

RD Head Support - Model 3 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421-MD
In Commercial Distribution

  • 05420028763506 ()


  • DNA-based tissue typing IVD, reagent

PMT® CORPORATION HALO - 00650551044888

VEST WAIST STRAP ASSEMBLY, INCLUDES: BUCKLE BLOCK, PLASTIC TAB, STRAP, HARDWARE
PMT CORPORATION
1201-46
In Commercial Distribution

  • 00650551044888 ()
1201-46

  • Cervical spine immobilization system, single-use
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