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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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NA - 10885862267047

Calcar Planer Blade, 2’’
Exactech, Inc.
01-003-04-0006
In Commercial Distribution

  • 10885862267047 ()

  • Outer Diameter: 2 Inch
01-003-04-0006

  • Bone-resection orthopaedic reamer, reusable

Omnia Medical TiBrid™-SC - 00843511105204

ANGLED CERVICAL DRILL,Ø2.0mm
OMNIA MEDICAL, LLC
10-5C-DRL1
In Commercial Distribution

  • 00843511105204 ()

  • Outer Diameter: 2 Millimeter
10-5C-DRL1

  • Fluted surgical drill bit, reusable

Urine Calibrator Set - 04250317539243

6PLUS1® Multilevel Urine Calibrator Set MassChrom® Total Metanephrines
Chromsystems Instruments + Chemicals GmbH
80739
In Commercial Distribution

  • 04250317539243 ()

  • Total Volume: 2 Milliliter
  • 7 Vials
80739

  • Multiple biogenic amine neurotransmitter IVD, calibrator

Urine Calibrator Set - 04250317537799

6PLUS1® Multilevel Urine Calibrator Set MassChrom® Catecholamines, free Metanephrines, Serotonin
Chromsystems Instruments + Chemicals GmbH
80639
In Commercial Distribution

  • 04250317537799 ()

  • Total Volume: 2 Milliliter
  • 7 Vials
80639

  • Multiple biogenic amine neurotransmitter IVD, calibrator

Urine Calibrator Set - 04250317525857

3PLUS1® Multilevel Urine Calibrator Set MassChrom® Methylmalonic Acid
Chromsystems Instruments + Chemicals GmbH
64029
In Commercial Distribution

  • 04250317525857 ()

  • Total Volume: 2 Milliliter
  • 4 Vials
64029

  • Methylmalonic acid (MMA) IVD, calibrator

Whole Blood Calibrator Set - 04250317521637

6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants
Chromsystems Instruments + Chemicals GmbH
28039/XL
In Commercial Distribution

  • 04250317521637 ()

  • Total Volume: 2 Milliliter
  • 7 Vials
28039/XL

  • Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

Plasma Calibrator Set - 04250317520777

3PLUS1® Multilevel Plasma Calibrator Set Imatinib, Dasatinib, Nilotinib
Chromsystems Instruments + Chemicals GmbH
58028
In Commercial Distribution

  • 04250317520777 ()

  • Total Volume: 2 Milliliter
  • 4 Vials
58028

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

Whole Blood Calibrator Set - 04250317505125

6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants
Chromsystems Instruments + Chemicals GmbH
28039
In Commercial Distribution

  • 04250317505125 ()

  • Total Volume: 2 Milliliter
  • 7 Vials
28039

  • Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

G-aenial™ - D0470123951

G-aenial™ Bulk Injectable A2
Gc America Inc.
012395
In Commercial Distribution

  • D0470123951 ()

  • Total Volume: 2 Milliliter
012395

  • Dental composite resin

G-aenial™ - D0470123941

G-aenial™ Bulk Injectable A1
Gc America Inc.
012394
In Commercial Distribution

  • D0470123941 ()

  • Total Volume: 2 Milliliter
012394

  • Dental composite resin
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