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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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Aquaplast RT Cosmas Cup, Size E
Qfix
RT-1597E
In Commercial Distribution

  • 10841962100110 ()
  • 10841962100127 ()

  • Length: 15 Centimeter
  • Width: 30 Centimeter
  • Depth: 2.4 Millimeter
RT-1597E

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size E
Qfix
RT-1597E
In Commercial Distribution

  • 10841962100103 ()

  • Length: 15 Centimeter
  • Width: 30 Centimeter
  • Depth: 2.4 Millimeter
RT-1597E

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size D
Qfix
RT-1597D
In Commercial Distribution

  • 10841962100080 ()
  • 10841962100097 ()

  • Width: 28 Centimeter
  • Depth: 2.4 Millimeter
  • Length: 10 Centimeter
RT-1597D

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size D
Qfix
RT-1597D
In Commercial Distribution

  • 10841962100073 ()

  • Depth: 2.4 Millimeter
  • Width: 28 Centimeter
  • Length: 10 Centimeter
RT-1597D

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size C
Qfix
RT-1597C
In Commercial Distribution

  • 10841962100059 ()
  • 10841962100066 ()

  • Depth: 2.4 Millimeter
  • Width: 25 Centimeter
  • Length: 8 Centimeter
RT-1597C

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size C
Qfix
RT-1597C
In Commercial Distribution

  • 10841962100042 ()

  • Length: 8 Centimeter
  • Depth: 2.4 Millimeter
  • Width: 25 Centimeter
RT-1597C

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size B
Qfix
RT-1597B
In Commercial Distribution

  • 10841962100028 ()
  • 10841962100035 ()

  • Width: 22 Centimeter
  • Depth: 2.4 Millimeter
  • Length: 5 Centimeter
RT-1597B

  • Patient positioning thermoplastic mould material
Aquaplast RT Cosmas Cup, Size B
Qfix
RT-1597B
In Commercial Distribution

  • 10841962100011 ()

  • Length: 5 Centimeter
  • Depth: 2.4 Millimeter
  • Width: 22 Centimeter
RT-1597B

  • Patient positioning thermoplastic mould material
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930410 ()
  • 00628341930413 ()
S-Bolus

  • Patient positioning thermoplastic mould material
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 00628341930406 ()
  • 10628341930403 ()
S-Bolus

  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Mask
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930380 ()
  • 00628341930383 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930373 ()
  • 00628341930376 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930229 ()
  • 00628341930222 ()


  • Patient positioning thermoplastic mould material
No Description
Merchsource, LLC
1017475
In Commercial Distribution

  • 00843479186611 ()


  • Foot bath
No Description
Merchsource, LLC
1014496, 1017308
In Commercial Distribution

  • 00843479153910 ()


  • Foot bath
No Description
Merchsource, LLC
1014495
In Commercial Distribution

  • 00843479153903 ()


  • Foot bath
HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
HUMIDIFIER SH870 115V US
FISHER & PAYKEL HEALTHCARE LIMITED
SH870JHU
In Commercial Distribution

  • 09420012433060 ()
SH870JHU

  • Insufflation gas conditioning system control unit
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX Analyzer
Spartan Bioscience Inc
01004777
In Commercial Distribution

  • 00628055420019 ()
01004777

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
VELA OPERATIONS SINGAPORE PTE. LTD.
300216
In Commercial Distribution

  • 08885013953664 ()
300216

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.
VELA OPERATIONS SINGAPORE PTE. LTD.
400125
In Commercial Distribution

  • 08885013950021 ()
400125

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen
Estill Medical Technologies, Inc.
TA-200
In Commercial Distribution

  • 00861816000314 ()
  • 00861816000307 ()
  • 00861816000321 ()


  • Convection blood/fluid warmer
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