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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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Carex Health Brands - 00815067043187

Pommel Cushion - 20 x 16
COMPASS HEALTH BRANDS CORP.
HDC-POM2016
In Commercial Distribution

  • 30815067043188 ()
  • 00815067043187 ()


  • Wheelchair seat cushion
  • Soft-rubber chair cushion

HIP Instruments - 07630040761017

Trial Augment 70/72 20
Medacta International SA
01.38.10.7020
In Commercial Distribution

  • 07630040761017 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760980

Trial Augment 66/68 20
Medacta International SA
01.38.10.6620
In Commercial Distribution

  • 07630040760980 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760959

Trial Augment 62/64 20
Medacta International SA
01.38.10.6220
In Commercial Distribution

  • 07630040760959 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760928

Trial Augment 58/60 20
Medacta International SA
01.38.10.5820
In Commercial Distribution

  • 07630040760928 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760898

Trial Augment 54/56 20
Medacta International SA
01.38.10.5420
In Commercial Distribution

  • 07630040760898 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760867

Trial Augment 50/52 20
Medacta International SA
01.38.10.5020
In Commercial Distribution

  • 07630040760867 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Cannula - 07615208379297

Cannula Luerlock 1.1mm black/20
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
597315
In Commercial Distribution

  • 07615208469899 ()
  • DVIV5973151 ()
  • 07615208379297 ()
597315

  • Dental material injection cannula, single-use

AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating - 00813132026868

2.5 mm x 20 mm
Philips Image Guided Therapy Corporation
2200-2520-B
In Commercial Distribution

  • 00813132026868 ()

  • Balloon Diameter: 2.5 Millimeter
  • Balloon Length: 20 Millimeter
2200-2520-B

  • Coronary angioplasty balloon catheter, cutting/scoring

IPS InLine - 07615208381917

IPS InLine Add-On 20 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
593343
In Commercial Distribution

593343

  • Dental appliance fabrication material, ceramic

AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating - 00813132026943

3.5 mm x 20 mm
Philips Image Guided Therapy Corporation
2200-3520-B
In Commercial Distribution

  • 00813132026943 ()

  • Balloon Diameter: 3.5 Millimeter
  • Balloon Length: 20 Millimeter
2200-3520-B

  • Coronary angioplasty balloon catheter, cutting/scoring

AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating - 00813132026905

3.0 mm x 20 mm
Philips Image Guided Therapy Corporation
2200-3020-B
In Commercial Distribution

  • 00813132026905 ()

  • Balloon Diameter: 3.0 Millimeter
  • Balloon Length: 20 Millimeter
2200-3020-B

  • Coronary angioplasty balloon catheter, cutting/scoring

AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating - 00813132026820

2.0 mm x 20 mm
Philips Image Guided Therapy Corporation
2200-2020-B
In Commercial Distribution

  • 00813132026820 ()

  • Balloon Diameter: 2.0 Millimeter
  • Balloon Length: 20 Millimeter
2200-2020-B

  • Coronary angioplasty balloon catheter, cutting/scoring

Tetric PowerFill - 07615208473360

Tetric PowerFill Refill Cavifil 20
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
759197WW
In Commercial Distribution

  • 07615208487756 ()
  • 07615208473360 ()
759197WW

  • Dental composite resin

OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel - 00813382010389

KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010075

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010006

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

IvoBase HI / IvoBase Hybrid - 07615208297515

IvoBase Hybrid Kit 20 Pink
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628883AN
In Commercial Distribution

628883AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208297508

IvoBase Hybrid Kit 20 Pink-V
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628884AN
In Commercial Distribution

628884AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208297492

IvoBase Hybrid Kit 20 Preference
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628885AN
In Commercial Distribution

628885AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208297461

IvoBase Hybrid Kit 20 Clear
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628888AN
In Commercial Distribution

628888AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208296662

IvoBase HI Kit 20 34-V
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
640933AN
In Commercial Distribution

640933AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208009439

IvoBase HI Kit 20 Preference
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628891AN
In Commercial Distribution

628891AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208009422

IvoBase HI Kit 20 Pink-V
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628890AN
In Commercial Distribution

628890AN

  • Denture base resin kit

IvoBase HI / IvoBase Hybrid - 07615208009415

IvoBase HI Kit 20 Pink
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628889AN
In Commercial Distribution

628889AN

  • Denture base resin kit

IPS Classic - 07615208406191

IPS Effect 20 g 1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
545017
In Commercial Distribution

545017

  • Dental appliance fabrication material, ceramic

IPS Classic - 07615208406184

IPS Effect 20 g 2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
545018
In Commercial Distribution

545018

  • Dental appliance fabrication material, ceramic

IPS Classic - 07615208406177

IPS Effect 20 g 3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
545019
In Commercial Distribution

545019

  • Dental appliance fabrication material, ceramic

IPS Classic - 07615208406160

IPS Effect 20 g 4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
545020
In Commercial Distribution

545020

  • Dental appliance fabrication material, ceramic

IPS Classic - 07615208406153

IPS Effect 20 g 5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
545021
In Commercial Distribution

545021

  • Dental appliance fabrication material, ceramic
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