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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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Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.
Hologic, Inc.
ThinPrep Genesis Processor
In Commercial Distribution

  • 15420045513860 ()
PRD-04573

  • Microscope slide maker IVD
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure.
Scibase AB
131-0007
In Commercial Distribution

  • 07350094440200 ()
131-0007

  • Neoplasm electrical impedance spectrometer electrode array
The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
37215
In Commercial Distribution

  • H628372151 ()
37215

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
In Commercial Distribution

  • 04987541300911 ()
00-1111-001-00

  • Synovial fluid supplementation medium
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
40012
Not in Commercial Distribution

  • M2480400120 ()
  • 10381780066590 ()

  • 12 mm dia x 15 mm L
40012

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040011
Not in Commercial Distribution

  • M2480400110 ()
  • 10381780066583 ()

  • 11 mm dia x 15 mm L
040011

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040010
In Commercial Distribution

  • M2480400100 ()
  • 10381780066576 ()

  • 10 mm dia x 15 mm L
040010

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040009
In Commercial Distribution

  • M2480400090 ()
  • 10381780066569 ()

  • 9 mm dia x 15 mm L
040009

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040008
In Commercial Distribution

  • M2480400080 ()
  • 10381780066552 ()

  • 8 mm dia x 15 mm L
040008

  • Subtalar implant, non-bioabsorbable
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
Not in Commercial Distribution

  • 00087541300912 ()
00-1111-001-00

  • Synovial fluid supplementation medium
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