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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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E2 Heavy-Duty MiniSet Removable Mounting Hardware - 07540147001209

E2 Heavy-Duty MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2MSHD
In Commercial Distribution

  • 07540147001209 ()
E2MSHD

  • Wheelchair back rest positioner

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

CareEvent - 00884838099128

CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver with the right information on a mobile device.
Philips Medical Systems Hsg
CareEvent
In Commercial Distribution

  • 00884838099128 ()
866435

  • Hospital-administration information system

NA - 00884838087965

No Description
Philips Medical Systems Hsg
C.02
In Commercial Distribution

  • 00884838087965 ()


  • Hospital-administration information system

NA - 00884838081284

No Description
Philips Medical Systems Hsg
B.01
In Commercial Distribution

  • 00884838081284 ()


  • Hospital-administration information system

NA - 00884838053441

No Description
Philips Medical Systems Hsg
A.01
In Commercial Distribution

  • 00884838053441 ()


  • Hospital-administration information system

IntelliSpace Event Management - 00884838031746

No Description
Philips Medical Systems Hsg
11.03
In Commercial Distribution

  • 00884838031746 ()


  • Hospital-administration information system

N/A - 04961333241989

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68403-ACC
In Commercial Distribution

  • 04961333241989 ()


  • Computer terminal

N/A - 04961333241972

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68391-ACC
In Commercial Distribution

  • 04961333241972 ()


  • Computer terminal
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