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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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Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Lumipulse BRAHMS PCT Controls - 04987270234945

No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

  • Size Type =Units per Kit; Units = 14; Unit of Measure = 20mLs


  • Procalcitonin (PCT) IVD, control

Lumipulse G BRAHMS PCT Calibrator Set - 04987270234938

No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

  • Size Type = Units per Kit; Units = 5; Unit of Measure = 10mLs


  • Procalcitonin (PCT) IVD, calibrator

Lumipulse B-Amyloid Controls - 04987270234907

No Description
FUJIREBIO INC.
234907
In Commercial Distribution

  • 04987270234907 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G Specimen Diluent 6 - 04987270234693

No Description
FUJIREBIO INC.
234693
In Commercial Distribution

  • 04987270234693 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G CA125II Immunoreaction Cartridges - 04987270234273

No Description
FUJIREBIO INC.
234273
In Commercial Distribution

  • 04987270234273 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Lumipulse G HE4 Calibrators - 04987270234181

No Description
FUJIREBIO INC.
234181
Not in Commercial Distribution

  • 04987270234181 ()

  • Size Type = Units Per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human epididymis protein 4 (HE4) IVD, calibrator

Lumipulse G CA 19-9-N Calibrators - 04987270230664

No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator

Lumipulse G CA 15-3 Calibrators - 04987270230640

No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

Lumipulse PTH Controls - 04987270230213

No Description
FUJIREBIO INC.
230213
Not in Commercial Distribution

  • 04987270230213 ()

  • Size Type = Units per Kit; Units = 4; Unit of Measure = 12mLs


  • Parathyroid hormone (PTH) IVD, control

Lumipulse G Whole PTH Calibrators - 04987270230206

No Description
FUJIREBIO INC.
230206
Not in Commercial Distribution

  • 04987270230206 ()

  • Size Type =Units per Kit; Units = 2; Unit of Measure = 4.5mLs


  • Parathyroid hormone (PTH) IVD, calibrator

Lumipulse G whole PTH Immunoreaction Cartridges - 04987270230190

No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

BD BBL™ GasPak™ 100 Anaerobic System, Vented - 00382902606277

BD BBL™ GasPak™ 100 Anaerobic System, Vented
BECTON, DICKINSON AND COMPANY
260627
Not in Commercial Distribution

  • 00382902606277 ()
260627

  • Atmospheric generation kit IVD

BD BBL™ GasPak™ 100 Anaerobic System - 00382902606260

BD BBL™ GasPak™ 100 Anaerobic System
BECTON, DICKINSON AND COMPANY
260626
Not in Commercial Distribution

  • 00382902606260 ()
260626

  • Atmospheric generation kit IVD

BD GasPak™ Catalyst Replacement Charges - 30382902703038

BD GasPak™ Catalyst Replacement Charges
BECTON, DICKINSON AND COMPANY
270303
Not in Commercial Distribution

  • 30382902703038 ()
  • 00382902703037 ()
270303

  • Atmospheric generation kit IVD

Trinity with XL Heads - 05055196937956

Trinity CoCrMo Modular Head 40mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
CORIN LTD
E321.340
In Commercial Distribution

  • 05055196937956 ()
E321.340

  • Metallic femoral head prosthesis

Trinity with XL Heads - 05055196937918

Trinity CoCrMo Modular Head 36mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
CORIN LTD
E321.336
In Commercial Distribution

  • 05055196937918 ()
E321.336

  • Metallic femoral head prosthesis

Trinity with XL Heads - 05055196937123

Trinity CoCr Modular Head Ø32mm EXTRA LONG +7.0mm 12/14 Eurocone Taper
CORIN LTD
E321.332
In Commercial Distribution

  • 05055196937123 ()
E321.332

  • Metallic femoral head prosthesis

Trinity with no TPS - 05055343880968

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø48mm Taper Size 2
CORIN LTD
320.02.348
In Commercial Distribution

  • 05055343880968 ()
320.02.348

  • Acetabular shell

Trinity with no TPS - 05055343880951

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø46mm Taper Size 1
CORIN LTD
320.01.346
In Commercial Distribution

  • 05055343880951 ()
320.01.346

  • Acetabular shell

Trinity with no TPS - 05055343880715

Trinity-i Non-occluded Titanium Plasma Spray Acetabular Shell Ø54mm Taper Size 4
CORIN LTD
320.04.354
In Commercial Distribution

  • 05055343880715 ()
320.04.354

  • Acetabular shell

Trinity with no TPS - 05055343880708

Trinity-i Non-occluded Titanium Plasma Spray Acetabular Shell Ø50mm Taper Size 3
CORIN LTD
320.03.350
In Commercial Distribution

  • 05055343880708 ()
320.03.350

  • Acetabular shell

Trinity with no TPS - 05055343880692

Trinity-i Non-occluded Titanium Plasma Spray Acetabular Shell Ø46mm Taper Size 2
CORIN LTD
320.02.346
In Commercial Distribution

  • 05055343880692 ()
320.02.346

  • Acetabular shell

Trinity with no TPS - 05055343880685

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø68mm Taper Size 5
CORIN LTD
320.05.368
In Commercial Distribution

  • 05055343880685 ()
320.05.368

  • Acetabular shell

Trinity with no TPS - 05055343880678

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø66mm Taper Size 5
CORIN LTD
320.05.366
In Commercial Distribution

  • 05055343880678 ()
320.05.366

  • Acetabular shell

Trinity with no TPS - 05055343880661

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø64mm Taper Size 5
CORIN LTD
320.05.364
In Commercial Distribution

  • 05055343880661 ()
320.05.364

  • Acetabular shell

Trinity with no TPS - 05055343880654

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø62mm Taper Size 5
CORIN LTD
320.05.362
In Commercial Distribution

  • 05055343880654 ()
320.05.362

  • Acetabular shell

Trinity with no TPS - 05055343880647

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø60mm Taper Size 5
CORIN LTD
320.05.360
In Commercial Distribution

  • 05055343880647 ()
320.05.360

  • Acetabular shell

Trinity with no TPS - 05055343880630

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø56mm Taper Size 4
CORIN LTD
320.04.356
In Commercial Distribution

  • 05055343880630 ()
320.04.356

  • Acetabular shell

Trinity with no TPS - 05055343880623

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø54mm Taper Size 3
CORIN LTD
320.03.354
In Commercial Distribution

  • 05055343880623 ()
320.03.354

  • Acetabular shell

Trinity with no TPS - 05055343880616

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø52mm Taper Size 3
CORIN LTD
320.03.352
In Commercial Distribution

  • 05055343880616 ()
320.03.352

  • Acetabular shell

Trinity with no TPS - 05055343880609

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø58mm Taper Size 4
CORIN LTD
320.04.358
In Commercial Distribution

  • 05055343880609 ()
320.04.358

  • Acetabular shell

Trinity with no TPS - 05055343880265

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø50mm Taper Size 2
CORIN LTD
320.02.350
In Commercial Distribution

  • 05055343880265 ()
320.02.350

  • Acetabular shell

Trinity with no TPS - 05055343880258

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø44mm Taper Size 1
CORIN LTD
320.01.344
In Commercial Distribution

  • 05055343880258 ()
320.01.344

  • Acetabular shell

PLASTIC WEDGES WITH HOLE - D89260705415281

No Description
MAXILL, INC.
6070541528
In Commercial Distribution

  • D89260705415280 ()
  • D89260705415281 ()


  • Dental wedge, single-use

PLASTIC WEDGES WITH HOLE - D89260705415271

No Description
MAXILL, INC.
6070541527
In Commercial Distribution

  • D89260705415270 ()
  • D89260705415271 ()


  • Dental wedge, single-use

PLASTIC WEDGES WITH HOLE - D89260705415261

No Description
MAXILL, INC.
6070541526
In Commercial Distribution

  • D89260705415260 ()
  • D89260705415261 ()


  • Dental wedge, single-use

RETRACTOR NEIMARK-SIDAL (WITH CURVE) - D9281055771S0

No Description
W.H. Holden, Inc.
10-5577-1S
In Commercial Distribution

  • D9281055771S0 ()


  • Dental cheek retractor, professional, reusable
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