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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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The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings
Biorep Technologies, Inc.
1.0
In Commercial Distribution

  • 00861361000241 ()
  • 00861361000234 ()
ISA-001

  • Irrigation syringe
DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.
MEDIMAGE, INC.
12
In Commercial Distribution

  • 00861333000309 ()


  • Multidisciplinary medical image management software
One pouched device, 1F002
Safepath Medical, Inc.
1F002
In Commercial Distribution

  • 00861298002622 ()


  • Silk suture
One pouched device, 1F001
Safepath Medical, Inc.
1F001
Not in Commercial Distribution

  • 00861298002608 ()
1F001

  • Silk suture
No Description
SOUNDCURE, INC.
900000
In Commercial Distribution

  • 00861259000209 ()


  • Air-conduction tinnitus masker, in-the-ear
The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
BELL-82380-A
In Commercial Distribution

  • 00861122000312 ()
  • 10861122000319 ()
BELL-82380-A

  • Haematological concentrate system preparation kit, platelet concentration
The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
CELL-80180-A
In Commercial Distribution

  • 10861122000302 ()
  • 00861122000305 ()
CELL-80180-A

  • Haematological concentrate system preparation kit, platelet concentration
Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
HOSPI CORPORATION
B
In Commercial Distribution

  • 00861003000226 ()
  • 10861003000223 ()
MCT-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Convenience kit for the Macy Catheter. Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer Lock Syringe, 3ml Exteral/Oral Syringe, 10ml Enteral/Oral Syringe, Macy Catheter Instructions for Use, Macy Catheter Bedside Care Kit Manual, Macy Catheter Medication Sheet (2), 3-Ply Poly Towel, Lubricating Jelly, Nitrile Gloves, Catheter Securing Device.
HOSPI CORPORATION
D
In Commercial Distribution

  • 00861003000219 ()
  • 10861003000216 ()
MCK-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
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