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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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Sectra Digital Pathology Module - 07350092810241

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.3
In Commercial Distribution

  • 07350092810241 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810197

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.2
In Commercial Distribution

  • 07350092810197 ()


  • Pathology information system

Leksell GammaPlan - 07340201502136

Leksell GammaPlan
Elekta Solutions AB
1567714
In Commercial Distribution

  • 07340201502136 ()


  • Stereotactic system application software

Leksell GammaPlan - 07340048311878

Leksell GammaPlan
Elekta Instrument AB
1551287
In Commercial Distribution

  • 07340048311878 ()


  • Stereotactic system application software

Leksell GammaPlan - 07340048311236

LGP 11.1
Elekta Instrument AB
1529980
In Commercial Distribution

  • 07340048311236 ()


  • Stereotactic system application software

Leksell GammaPlan - 07340048311229

LGP 11.1 SW MEDIA
Elekta Instrument AB
1529604
Not in Commercial Distribution

  • 07340048311229 ()
1529980

  • Stereotactic system application software

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

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

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 - 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. - 04048551009864

Optical Mouse
Karl Storz GmbH & Co. KG
40800028
In Commercial Distribution

  • 04048551009864 ()


  • Computer terminal

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

Spex Limited - 09420051745599

Spex Back Support Heavy Duty Quad Mount Hardware, for all sized wheelchairs
SPEX LIMITED
1259-2405-100
In Commercial Distribution

  • 09420051745599 ()


  • Wheelchair back rest

Assembly Required Distributors - 00854362008668

Back frame for doctor stainless steel stool, complete with hardware, no uph.. -
Assembly Required Distributors Inc
CHM8904-01
In Commercial Distribution

  • 00854362008668 ()


  • Chair/stool armrest

PMT CORPORATION HALO - 00650551141686

TRACTION BAIL HARDWARE - (2) 3/4" SHCS, (2) WASHERS, (1) ALLEN WRENCH
PMT CORPORATION
1206-17
In Commercial Distribution

  • 00650551141686 ()
1206-17

  • Cervical spine immobilization system, single-use

Millennium - 00190776151270

Accessory Box single level, w/o hardware, 1.5" x 3.5" x 1"
Avalign Technologies, Inc.
95-2000100016
In Commercial Distribution

  • 00190776151270 ()


  • Device sterilization/disinfection container, reusable

Pilling - 00190776134334

Accessory Box single level, w/o hardware,1.5" x 3.5" x 1"
Avalign Technologies, Inc.
P37593
In Commercial Distribution

  • 00190776134334 ()


  • Device sterilization/disinfection container, reusable

Skytron 32" Shelf with handles E3 - 10841736113971

32" Shelf with handles for XM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3XMSH-H
In Commercial Distribution

  • 10841736113971 ()


  • General utility supply system, ceiling-mounted

Skytron 22" Shelf with handles E3 - 10841736113902

22" Shelf with handles for PM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3PMSH-H
In Commercial Distribution

  • 10841736113902 ()


  • General utility supply system, ceiling-mounted

Skytron 16.5" Shelf with handles E3 - 10841736113872

16.5" Shelf with handles for KM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3KMSH-H
In Commercial Distribution

  • 10841736113872 ()


  • General utility supply system, ceiling-mounted

Avalign - 00190776128395

Accessory Box single level, w/o hardware, 1.5" x 3.5" x 1"
Avalign Technologies, Inc.
2000-100-016
In Commercial Distribution

  • 00190776128395 ()


  • Device sterilization/disinfection container, reusable

Axiom - 00840363367910

4 x 5 Lateral Pads, Curved with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367910 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLSC4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367897

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367897 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367880

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367880 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLS3x4L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367873

4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367873 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLFM4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367866

3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367866 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLFM3x4L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367811

4 x 5 Lateral Pads, Curved with S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367811 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLSC4x5R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367804

3 x 4 Lateral Pads, Curved with S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367804 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLSC3x4R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367798

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367798 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLS4x5R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367781

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367781 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3x4R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367774

4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367774 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLFM4x5R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367767

3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367767 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLFM3x4R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367712

4 x 5 Lateral Pads, Curved with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367712 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLSC4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367705

3 x 4 Lateral Pads, Curved with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367705 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLSC3x4L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367699

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367699 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367682

3 x 4 Lateral Pads, Flat with S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367682 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3x4L

  • Wheelchair head/trunk support, prefabricated
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