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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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Go Hearing - Go Ultra - Gray - BTE - WAG Online
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online
In Commercial Distribution

  • 00810153660057 ()


  • Air-conduction hearing aid, behind-the-ear
Basin wrap 50"x50" 2.25m;on-line lam,1800pc/G
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080555 ()
  • 00683534080559 ()
BW50050-1

  • Medical equipment/instrument drape, single-use
Basin wrap 50"x76" 2.25m;on-line lam, 1170pc/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080562 ()
  • 00683534080566 ()
BW50076-1

  • Medical equipment/instrument drape, single-use
Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online - CASE
In Commercial Distribution

  • 10810153660054 ()
GHUS00002CA

  • Air-conduction hearing aid, behind-the-ear
HPLC Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38910
In Commercial Distribution

  • 04250317523822 ()

  • 1 pcs.
38910

  • High performance liquid chromatography analyser column IVD
Trap Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38920
In Commercial Distribution

  • 04250317523761 ()

  • 1 pcs.
38920

  • High performance liquid chromatography analyser column IVD
No Description
Roche Diagnostics GmbH
3516989190
Not in Commercial Distribution

  • 04015630997138 ()
3516989190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
3510620190
Not in Commercial Distribution

  • 04015630997060 ()
3510620190

  • Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
3376222190
Not in Commercial Distribution

  • 04015630996933 ()
3376222190

  • Lidocaine therapeutic drug monitoring IVD, reagent
No Description
Roche Diagnostics GmbH
20737976122
In Commercial Distribution

  • 04015630993468 ()
20737976122

  • Barbiturate IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08445567190
In Commercial Distribution

  • 07613336157787 ()
08445567190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08253161190
In Commercial Distribution

  • 07613336147948 ()
08253161190

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08253153190
In Commercial Distribution

  • 07613336147931 ()
08253153190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08252670190
In Commercial Distribution

  • 07613336147917 ()
08252670190

  • Quinidine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08252661190
In Commercial Distribution

  • 07613336147900 ()
08252661190

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08252637190
In Commercial Distribution

  • 07613336147870 ()
08252637190

  • N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08105383190
In Commercial Distribution

  • 07613336133514 ()
08105383190

  • Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08057613190
In Commercial Distribution

  • 07613336121214 ()
08057613190

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
09230815190
In Commercial Distribution

  • 07613336224823 ()
09230815190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
09230785190
In Commercial Distribution

  • 07613336224816 ()
09230785190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08814708190
In Commercial Distribution

  • 07613336166109 ()
08814708190

  • Methaqualone IVD, reagent
No Description
Roche Diagnostics GmbH
08058601190
Not in Commercial Distribution

  • 07613336121474 ()
08058601190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08058580190
In Commercial Distribution

  • 07613336121467 ()
08058580190

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
TUBING CB4716R1 10PK CB TMC50 W/6INCH LN
MEDTRONIC, INC.
CB4716R1
Not in Commercial Distribution

  • 20673978564214 ()
  • 00673978564210 ()

  • Length: 152.0 Millimeter


  • Cardiopulmonary bypass system blood tubing set
TUBING CB4714R1 10PK CB TMC25 W/6INCH LN
MEDTRONIC, INC.
CB4714R1
Not in Commercial Distribution

  • 20673978564177 ()
  • 00673978564173 ()

  • Length: 152.0 Millimeter


  • Cardiopulmonary bypass system blood tubing set
CELL 1475R1 TMC50 W/6 INCH EXTENSION
MEDTRONIC, INC.
1475R1
In Commercial Distribution

  • 20673978538420 ()
  • 00673978538426 ()


  • Extracorporeal membrane oxygenator
CELL 1474R1 TMC38 W/6 FT EXTENSION
MEDTRONIC, INC.
1474R1
In Commercial Distribution

  • 20673978538406 ()
  • 00673978538402 ()


  • Extracorporeal membrane oxygenator
CONN TMC38 BIOTREND 3/8 CUVETTE 12PK
MEDTRONIC, INC.
TMC38
In Commercial Distribution

  • 20681490009823 ()
  • 00681490009829 ()

  • 0.95 CM Port Outer Diameter


  • Cardiopulmonary bypass system blood gas sensor
CONN TMC25 BIOTREND 1/4 CUVETTE 12PK
MEDTRONIC, INC.
TMC25
In Commercial Distribution

  • 20681490009816 ()
  • 00681490009812 ()

  • 0.64 CM Port Outer Diameter


  • Cardiopulmonary bypass system blood gas sensor
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