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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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FENTANYL CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
FENT+ CAL 5 U F KP
In Commercial Distribution

  • B800FENTCAL5UFKP5 ()
  • B800FENTCAL5UFKP0 ()

  • Total Volume: 1 Milliliter
FENT+ CAL 5 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
OPI U CAL 5 UNC
In Commercial Distribution

  • B800OPIUCAL5UNC5 ()
  • B800OPIUCAL5UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 5 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
MYCOPHENOLIC ACID LEVEL 5
UTAK LABORATORIES, INC.
MPA 5 S MAYO
In Commercial Distribution

  • B800MPA5SMAYO5 ()
  • B800MPA5SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 5 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
5 VIALS
SEBIA
4795
In Commercial Distribution

  • 03607360047958 ()
4795

  • Carbohydrate deficient transferrin IVD, control
No Description
SEBIA
4781
In Commercial Distribution

  • 03607360047811 ()
4781

  • Protein electrophoresis IVD, control
No Description
SEBIA
4759
In Commercial Distribution

  • 03607360047590 ()
4759

  • Haemoglobin detection IVD, control
temporary cement, non eugenol
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03710
In Commercial Distribution

  • EBIB037101 ()
03710

  • Zinc polycarboxylate dental cement
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190011529 ()
PO1-0005

  • Dental implant system
115V OCSI 10LPM OXYGEN CONCENTRATOR - EXTRA ACCESSORIES
NIDEK MEDICAL PRODUCTS, INC.
595NSH
In Commercial Distribution

  • 00038214001612 ()
595NSH

  • Stationary oxygen concentrator
230V OCSI 10LPM OXYGEN CONCENTRATOR -- INDIA PLUG
NIDEK MEDICAL PRODUCTS, INC.
1005NI
In Commercial Distribution

  • 00038214001605 ()
1005NI

  • Stationary oxygen concentrator
230V OCSI 10LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE
NIDEK MEDICAL PRODUCTS, INC.
1005GC
In Commercial Distribution

  • 00038214001599 ()
1005GC

  • Stationary oxygen concentrator
115V OCSI OXYGEN CONCENTRATOR -- FOR CANADA, FRENCH MANUAL
NIDEK MEDICAL PRODUCTS, INC.
525CA
In Commercial Distribution

  • 00038214001582 ()
525CA

  • Stationary oxygen concentrator
230V OCSI 10LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE, UK PLUG
NIDEK MEDICAL PRODUCTS, INC.
1005GCUK
In Commercial Distribution

  • 00038214001575 ()
1005GCUK

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE, UK PLUG
NIDEK MEDICAL PRODUCTS, INC.
925GCUK
In Commercial Distribution

  • 00038214001568 ()
925GCUK

  • Stationary oxygen concentrator
230V OCSI 8LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE, UK PLUG
NIDEK MEDICAL PRODUCTS, INC.
985GCUK
In Commercial Distribution

  • 00038214001551 ()
985GCUK

  • Stationary oxygen concentrator
230V OCSI 8 LPM OXYGEN CONCENTRATOR -- INDIA PLUG
NIDEK MEDICAL PRODUCTS, INC.
985NI
In Commercial Distribution

  • 00038214001544 ()
985NI

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR - PRIVATE LABELED FOR CLEANETICA
NIDEK MEDICAL PRODUCTS, INC.
925-OCSI
In Commercial Distribution

  • 00038214001520 ()
925-OCSI

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR - PRIVATE LABELED FOR BEIRUT MEDICAL CENTER
NIDEK MEDICAL PRODUCTS, INC.
925BMC
In Commercial Distribution

  • 00038214001513 ()
925BMC

  • Stationary oxygen concentrator
115V OCSI OXYGEN CONCENTRATOR WITH NEB KIT
NIDEK MEDICAL PRODUCTS, INC.
525NEB
In Commercial Distribution

  • 00038214001490 ()
525NEB

  • Stationary oxygen concentrator
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