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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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Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
BIO-MED DIAGNOSTICS, INC.
1303
In Commercial Distribution

  • B08813034 ()
  • B08813030 ()
  • B08813032 ()
21-303-001

  • Mannitol-salt Staphylococcus species agar culture medium IVD
The Integra Total Foot System mini calcaneus plate is a low profile,less invasive plate fixation for calcaneal fracture procedures. It reduces the need for a large calcaneal flap incision in most cases.
Ascension Orthopedics, Inc.
2805007
Not in Commercial Distribution

  • 10381780118305 ()
  • M26828050071 ()

  • 57.93mm L x 42.63mm W x 1.3mm H
2805007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System mini calcaneus plate is a low profile, less invasive plate fixation for calcaneal fracture procedures. It reduces the need for a large calcaneal flap incision in most cases.
Ascension Orthopedics, Inc.
2805006
Not in Commercial Distribution

  • 10381780118299 ()
  • M26828050061 ()

  • 46.69mm L x 16.67mm W x 1.3mm H
2805006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material
Container Specimen 90 Milliliter With Patient Label Tamper-Evident Seal Leak-Proof Wide Mouth Orange Lid Sterile In Operating Room Peel Pouch Pneumatic Tube Approved Single Patient Use Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
SPC405OR
In Commercial Distribution

  • 50885632133150 ()
  • 10885632133152 ()


  • General specimen container IVD, no additive, sterile
The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9507-0
In Commercial Distribution

  • 00607158000069 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.
PFIZER INC.
F000092379
In Commercial Distribution

  • 10300130923796 ()


  • Basic growth hormone autoinjector, replaceable-cartridge
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000QB
In Commercial Distribution

  • D678D5000QB0 ()
  • D678D5000QB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000Q
In Commercial Distribution

  • D678D5000Q0 ()
  • D678D5000Q1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000FB
In Commercial Distribution

  • D678D5000FB0 ()
  • D678D5000FB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
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