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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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GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-36
In Commercial Distribution

  • 00855920006591 ()

  • Height: 10.0 Centimeter
  • Length: 20.0 Centimeter
CE0408

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-30
In Commercial Distribution

  • 00855920006577 ()

  • Height: 5.0 Centimeter
  • Length: 15.0 Centimeter
CE0206

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mounting Medium
In Commercial Distribution

  • 00673693073189 ()
4111

  • Microscopy mounting medium IVD
Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mounting Medium
In Commercial Distribution

  • 00673693170383 ()
4112

  • Microscopy mounting medium IVD
This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Persona Medical
Ole Deep CIC Custom Hearing Aid
Not in Commercial Distribution

  • 00851362008315 ()


  • Air-conduction hearing aid, in-the-ear
The CNMC Model 206 is a medical dosimeter or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected.
CNMC CO., INC.
206
In Commercial Distribution

206

  • Radiation electrometer
Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0007151
In Commercial Distribution

  • 10888234000723 ()
0007151

  • Anti-H red blood cell grouping IVD, lectin
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected.
CNMC CO., INC.
206
Not in Commercial Distribution

  • 08622460003012 ()
206

  • Radiation electrometer
The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Braebon Medical Corporation
MBJR-WN
In Commercial Distribution

  • B140MBJRWN0 ()
MBJR-WN

  • Polysomnograph
CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B40200LR
In Commercial Distribution

  • 04540778163515 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 4.0 mm
BD-B40200LR

  • Peripheral angioplasty balloon catheter, basic
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