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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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HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-5346
In Commercial Distribution

  • 54987350866290 ()
  • 04987350866295 ()

  • Shape name of distal shaft is JR4.5
  • Outer Diameter: 1.75 Millimeter
  • Pressure: 4826 KiloPascal
  • Length: 100 Centimeter
  • Lumen/Inner Diameter: 1.47 Millimeter
GC-U5JR450N

  • Vascular guide-catheter, single-use
A separate 60 drops,60" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48", 3-Way White OFF stopcock and 12" Pressure tubing. It also includes a separately packed 2x male protective caps.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682128
In Commercial Distribution

  • 50886333621281 ()
  • 00886333621286 ()

  • Adset is 60 drops, tube length 60"
682128

  • Pressure transducer dome, single-use
Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Iduronate 2-sulfatase activity with a tandem mass spectrometer (MS/MS).
Wallac Oy
4400-0010
In Commercial Distribution

  • 06438147386963 ()
4400-0010

  • Assay development analyte-specific reagent IVD
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008084 ()
C13112-5

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Set screw Wrong DI Number
Corentec Co., Ltd
00.00.0000
In Commercial Distribution

  • 08806373812910 ()


  • Bone-screw internal spinal fixation system, non-sterile
Pedicle screw(Standard, Blasting+Anodizing)
Corentec Co., Ltd
01.22.607
In Commercial Distribution

  • 08806373811388 ()


  • Bone-screw internal spinal fixation system, non-sterile
Sleeve
Corentec Co., Ltd
01.21.010
In Commercial Distribution

  • 08806373810459 ()


  • Bone-screw internal spinal fixation system, non-sterile
Rod-B
Corentec Co., Ltd
01.21.073
In Commercial Distribution

  • 08806373837005 ()


  • Bone-screw internal spinal fixation system, non-sterile
Pedicle screw
Corentec Co., Ltd
01.21.558
In Commercial Distribution

  • 08806373810855 ()


  • Bone-screw internal spinal fixation system, non-sterile
Pedicle screw(Guided, Blasting) DI should be "08800017226552"
Corentec Co., Ltd
01.27.616
In Commercial Distribution

  • 08806373816130 ()


  • Bone-screw internal spinal fixation system, non-sterile
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