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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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Azur Detachable Helical HydroCoil - 00810170018077

Azur
MICROVENTION INC.
45-482020
In Commercial Distribution

  • 00810170018077 ()

  • 20 mm x 20 cm
45-482020

  • Non-neurovascular embolization coil

Azur Detachable Helical HydroCoil - 00810170015038

Azur
MICROVENTION INC.
45-452020
In Commercial Distribution

  • 00810170015038 ()

  • 20 mm x 20 cm
45-452020

  • Non-neurovascular embolization coil

HARDCORE® - D701HC2

CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas
PULPDENT CORPORATION
HC
Not in Commercial Distribution

  • D701HC2 ()

  • Weight: 20 Gram


  • Dental composite resin

Camino® - 10381780039563

Camino® Single Parameter Monitoring Cable
INTEGRA LIFESCIENCES (IRELAND) LIMITED
PAC2
Not in Commercial Distribution

  • M273PAC21 ()
  • 10381780039563 ()
PAC2

  • Electrical-only medical device connection cable, reusable

Camino® - 10381780023951

The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino Flex catheter products to support the direct and continuous measurement of intracranial pressure (ICP) and intracranial temperature (ICT) when connected to the MPM or Camino CAM01 intracranial pressure ICP monitor. The device is a reusable product.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
PAC1
Not in Commercial Distribution

  • M273PAC11 ()
  • 10381780023951 ()


  • Electrical-only medical device connection cable, reusable

Composi-Tight 3D Fusion Sectional Matrix System - 00810038090450

1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fusion wedges (20 each), 1 FXP01, 4x Varistrips, 5x Margin Elevation bands
GARRISON DENTAL SOLUTIONS, L.L.C.
FX-KFF-00-VM
In Commercial Distribution

  • 00810038090450 ()


  • Dental matrix band kit

Face a Face - 03663524273533

No Description
Design Eyewear Group International A/S
FFBOCCAPIXIES2/1946
In Commercial Distribution

  • 03663524273533 ()


  • Tinted non-prescription spectacles

Alinity - 00380740193829

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740193805

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
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