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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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OPRA Implant System - 07340152101303

Axor Extension Plate 20 mm
Integrum AB
1167
In Commercial Distribution

  • 07340152101303 ()
1167

  • Internal-external leg prosthesis osseointegration bar

Ascension MCP Joint Replacement - 00885556856741

MCP SZ. 20 PROXIMAL WW
Smith & Nephew, Inc.
MCP-100-20P-WW
In Commercial Distribution

  • 00885556856741 ()
MCP-100-20P-WW

  • Metacarpophalangeal joint prosthesis, modular

Ascension MCP Joint Replacement - 00885556856734

MCP SZ. 20 DISTAL WW
Smith & Nephew, Inc.
MCP-100-20D-WW
In Commercial Distribution

  • 00885556856734 ()
MCP-100-20D-WW

  • Metacarpophalangeal joint prosthesis, one-piece

HER2 CISH pharmDx™ Kit - 05700572032960

HER2 CISH pharmDx Kit
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK109
In Commercial Distribution

  • 05700572032960 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)

HER2 IQFISH pharmDx™ - 05700572032465

HER2 IQFISH pharmDx™
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5731
In Commercial Distribution

  • 05700572032465 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)

MONOLISA™ - 00847865002042

MONOLISA™ Anti-HBs EIA Calibrator Kit
Bio-RAD Laboratories, Inc.
25219
In Commercial Distribution

  • 00847865002042 ()

  • 20 Tests
25219

  • Hepatitis B virus surface total antibody IVD, calibrator

EDWARDS COMMANDER DELIVERY SYSTEM - 00690103193930

EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS20
In Commercial Distribution

  • 00690103193930 ()

  • 20 MM
9600LDS20A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

Compress Device - 00880304461666

No Description
Biomet Orthopedics, LLC
178562
In Commercial Distribution

  • 00880304461666 ()

  • 20 MM
178562

  • Knee femur stem prosthesis

ACRYSOF® IQ RESTOR® - 00380655101117

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101117 ()

  • Diopter 20


  • Posterior-chamber intraocular lens, pseudophakic

AcrySof® ACRYSERT® - 00380655097465

AcrySof(R) IQ ASPHERIC Natural SP IOL WITHTHE AcrySert(R) DELIVERY SYSTEM, UV WITH BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60WS
Not in Commercial Distribution

  • 00380655097465 ()

  • Diopter 20
SN60WS.200

  • Posterior-chamber intraocular lens, pseudophakic
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