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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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DRYASOL - B467ACP4522575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate

SPEAX Patch for Home Use - B792FGN010

Patch for use with the SPEAX Digital Communication System for Home Use
ATAIA INC.
FGN-010
In Commercial Distribution

  • B792FGN010 ()
  • B792FGN014 ()
  • B792FGN015 ()
  • B792FGN016 ()
FGN010

  • Voice amplification system

InoMesh - MDLXMAG120300

MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG120200

MAG1-2020: 20cm x 20cm (8in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2020
In Commercial Distribution

  • MDLXMAG120200 ()
  • MDLXMAG120203 ()
  • MDLXMAG120202 ()
  • MDLXMAG120201 ()
MAG1-2020

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115200

MAG1-1520: 15cm x 20cm (6in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1520
In Commercial Distribution

  • MDLXMAG115200 ()
  • MDLXMAG115203 ()
  • MDLXMAG115202 ()
  • MDLXMAG115201 ()
MAG1-1520

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115150

MAG1-1515: 15cm x 15cm (6in x 6in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1515
In Commercial Distribution

  • MDLXMAG115150 ()
  • MDLXMAG115153 ()
  • MDLXMAG115152 ()
  • MDLXMAG115151 ()
MAG1-1515

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115100

MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1510
In Commercial Distribution

  • MDLXMAG115100 ()
  • MDLXMAG115103 ()
  • MDLXMAG115102 ()
  • MDLXMAG115101 ()
MAG1-1510

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

QuickProfile™ Amphetamine Test Card - M90174014

Immunoassay for the detection of amphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
74014
In Commercial Distribution

  • M90174014 ()
  • M901740141 ()
  • M901740143 ()
  • M901740142 ()

  • Length: 75 Millimeter
74014

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

MARK3 - D79690131

Alginate Alternative 380 Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9013
In Commercial Distribution

  • D7969013 ()
  • D79690131 ()
  • D79690132 ()
  • D79690133 ()
  • D79690134 ()
9013

  • Silicone dental impression material

MES 9000 Musculoskeletal System - D792N9000M0

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
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