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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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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
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
R170 - The PDT Montana Explorer™ is the perfect companion for the Montana Jack, featuring the same contra-angle providing better universal adaptation.
PDT, INC.
R170 Montana Explorer
In Commercial Distribution

  • 00813677021151 ()
R170

  • Dental surgical probe, reusable
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
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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
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
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
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
08445567190
In Commercial Distribution

  • 07613336157787 ()
08445567190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Quantum Diagnostic Module
SPECTRUM MEDICAL LIMITED
QDM1
In Commercial Distribution

  • 05060434420701 ()
51-000023-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m
SPECTRUM MEDICAL LIMITED
HBS2-130
In Commercial Distribution

  • 05060434420664 ()
51-000043-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS4-130
In Commercial Distribution

  • 05060434420640 ()
51-000041-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m
SPECTRUM MEDICAL LIMITED
HBS2-200
In Commercial Distribution

  • 05060434420626 ()
51-000039-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m
SPECTRUM MEDICAL LIMITED
HBS4-200
In Commercial Distribution

  • 05060434420602 ()
51-000037-00

  • Extracorporeal blood gas/pH monitor
Exhaust Module for use with Gas Modules as part of Gas Management System
SPECTRUM MEDICAL LIMITED
Exhaust Module
In Commercial Distribution

  • 05060434420206 ()
3003-031-005

  • Extracorporeal blood gas/pH monitor
Low Flow - (0.5 - 3.0 L/min)
SPECTRUM MEDICAL LIMITED
Gas Module
Not in Commercial Distribution

  • 05060434420183 ()
3003-030-011

  • Extracorporeal blood gas/pH monitor
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