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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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RamSoft - B359GWR6PRU100

RamSoft Gateway Router 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359GWR6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359GWR60

RamSoft Gateway Router 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359GWR60 ()
GWR6

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

RamSoft - B359PSPACS6PRU9GA0

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.9.9061
In Commercial Distribution

  • B359PSPACS6PRU9GA0 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

RamSoft - B359PSPACS6PRU910

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.9.9110
In Commercial Distribution

  • B359PSPACS6PRU910 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359PSPACS6PRU90

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359PSPACS6PRU90 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359PSPACS6PRU80

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.8.8111
In Commercial Distribution

  • B359PSPACS6PRU80 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

RamSoft - B359PSPACS6PRU720

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359PSPACS6PRU720 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

RamSoft - B359PSPACS6PRU70

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359PSPACS6PRU70 ()
PSPACS6PRU7

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

RamSoft - B359PSPACS6PRU60

RamSoft PowerServer PACS
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359PSPACS6PRU60 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359PSPACS6PRU510

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution

  • B359PSPACS6PRU510 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359PSPACS6PRU100

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359PSPACS6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

RamSoft - B359PSPACS60

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359PSPACS60 ()
PSPACS6

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

Extremity Care - 00850003042381

Basket Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Basket Cannula Tube ID:2.5mm, OD:3.0mm
Extremity Care
ALC425
In Commercial Distribution

  • 00850003042381 ()


  • Tissue injection cannula

Extremity Care - 00850003042268

Straight Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Straight Cannula Tube ID:2.5mm, OD:3.0mm
Extremity Care
ALC125
In Commercial Distribution

  • 00850003042268 ()


  • Tissue injection cannula

EPI-DERM - 00852260000944

Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair
Biodermis LLC
ELP-51
In Commercial Distribution

  • 00852260000944 ()
ELP-51

  • Scar-management dressing, reusable

EPI-DERM - 00852260000937

Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
Biodermis LLC
ELP-1
In Commercial Distribution

  • 00852260000937 ()
ELP-1

  • Scar-management dressing, reusable

VASCU-SHEATH® - 00884908144352

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1902422
In Commercial Distribution

  • 50884908144357 ()
  • 30884908144353 ()
  • 00884908144352 ()
DMR1902422

  • Vascular catheter introduction needle

VASCU-SHEATH® - 00884908144321

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1902222
In Commercial Distribution

  • 30884908144322 ()
  • 00884908144321 ()
  • 50884908144326 ()
DMR1902222

  • Vascular catheter introduction needle

VASCU-SHEATH® - 00884908145472

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1903422
In Commercial Distribution

  • 30884908145473 ()
  • 00884908145472 ()
  • 50884908145477 ()
DMR1903422

  • Vascular catheter introduction needle

VASCU-SHEATH® - 00884908145441

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1903222
In Commercial Distribution

  • 50884908145446 ()
  • 30884908145442 ()
  • 00884908145441 ()
DMR1903222

  • Vascular catheter introduction needle

ProTrack Microcatheter - 00685447000624

No Description
Baylis Médicale Cie Inc
CIC 38-145
Not in Commercial Distribution

  • 00685447000624 ()

  • Length: 145 Centimeter
  • Outer Diameter: 0.038 Inch
  • Body ID = 0.027 inch, Tapered end ID = 0.025 inch


  • Peripheral vascular intervention infusion catheter

ProTrack Microcatheter - 00685447000617

No Description
Baylis Médicale Cie Inc
CIC 35-145
Not in Commercial Distribution

  • 00685447000617 ()

  • Length: 145 Centimeter
  • Outer Diameter: 0.035 Inch
  • Body ID = 0.024 inch, Tapered end ID = 0.022 inch


  • Peripheral vascular intervention infusion catheter

ProTrack Microcatheter - 07540299000198

No Description
Baylis Medical Technologies Inc
CIC38-145
In Commercial Distribution


  • Body ID = 0.027 inch, Tapered end ID = 0.025 inch
  • Outer Diameter: 0.038 Inch
  • Length: 145 Centimeter


  • Peripheral vascular intervention infusion catheter

ProTrack Microcatheter - 07540299000181

No Description
Baylis Medical Technologies Inc
CIC35-145
In Commercial Distribution


  • Body ID = 0.024 inch, Tapered end ID = 0.022 inch
  • Outer Diameter: 0.035 Inch
  • Length: 145 Centimeter


  • Peripheral vascular intervention infusion catheter

Clear Guide CORE - B201CGCORE24MR0

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer

Clear Guide CORE - B201CGCORE240

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer

Austin - 00850017635418

Mother’s Viewing Drape with Bleed ID Window
AUSTIN MEDICAL
A-AU-10-122S
In Commercial Distribution

  • 00850017635425 ()
  • 00850017635418 ()
A-AU-10-122S

  • Patient surgical drape, single-use

DxTx Medical 3T eCoil Imaging Device (FRU for Siemens) - 00850011472187

Ecoil ID - STID TIM 30 FRU - 8624855
DXTX MEDICAL INC
STID TIM 30 FRU
In Commercial Distribution

  • 00850011472187 ()


  • MRI system coil, radio-frequency

DxTx Medical 1.5 T eCoil Imaging System (For Philips) - 00850011472057

eCoil ID - 1.5T Philips Ingenia Assy - 9896-030-19121
DXTX MEDICAL INC
9896-030-19121
In Commercial Distribution

  • 00850011472057 ()


  • MRI system coil, radio-frequency

DxTx Medical 3T eCoil Imaging Device (for Philips) - 00850011472040

Ecoil ID - 3.0T Philips Ingenia Assy - 9896-030-19031
DXTX MEDICAL INC
9896-030-19031
In Commercial Distribution

  • 00850011472040 ()


  • MRI system coil, radio-frequency
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