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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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Lumbar Interbody Fusion System (OLLIF) - 00850014575038

Lumbar Interbody Fusion System (OLLIF) Instrument Set in Sterilization Case
ADVANCED RESEARCH MEDICAL LLC
01-2001
In Commercial Distribution

  • 00850014575038 ()
01-2001

  • Instrument tray, reusable
  • Metallic spinal interbody fusion cage

Orfit Industries - 05420028792230

3pt Head Mask - Nose Hole In Nanor 1.6 mm Micro+
Orfit Industries NV
35763/16MI+N
In Commercial Distribution

  • 05420028792230 ()


  • Head/neck procedure positioner

Orfit Industries - 05420028777978

4pt HNS Mask - Nose Hole In Nanor 2.0 mm Micro+
Orfit Industries NV
35764/2MI+N
In Commercial Distribution

  • 05420028777978 ()


  • Head/neck procedure positioner

Orfit Industries - 05420028771594

2pt Breast Mask - 4 push-pin profile in Efficast 2mm MAXI
Orfit Industries NV
35797/2MA/NP
In Commercial Distribution

  • 05420028771594 ()


  • Head/neck procedure positioner

Orfit Industries - 05420028767894

LOXON™ Set in plastic Long Base Plates - MRI compatible
Orfit Industries NV
32181
In Commercial Distribution

  • 05420028767894 ()


  • DNA-based tissue typing IVD, reagent

Factor VIII Chromogenic Assay - 00630414640389

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873840
In Commercial Distribution

  • 00630414640389 ()
10873840

  • Coagulation factor VIII IVD, kit, chromogenic

INNOVANCE® D-Dimer Sample Diluent - 00630414639666

For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10873905
In Commercial Distribution

  • 00842768019265 ()
  • 00630414639666 ()
10873905

  • Buffered sample diluent IVD

Vital Signs™ - 10190752181175

300-Series ECG Leadwire, 3-lead, Snap, AHA, 75 cm/ 30 in
AIRLIFE
545327-HEL
In Commercial Distribution

545327-HEL

  • Electrocardiographic lead set, reusable

Vital Signs™ - 10190752181151

300-Series ECG Leadwire, 3-lead, Grabber, AHA, 75 cm/ 30 in
AIRLIFE
545317-HEL
In Commercial Distribution

545317-HEL

  • Electrocardiographic lead set, reusable

Vital Signs™ - 10190752181137

300-series ECG Leadwire, 3-lead, Grabber, IEC, 75 cm/30 in
AIRLIFE
545315-HEL
In Commercial Distribution

  • 10190752181137 ()
545315-HEL

  • Electrocardiographic lead set, reusable
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