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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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Comfort Colors - 08101405701164

No Description
New York Optical-International, Inc.
Brown / -01.25
Not in Commercial Distribution

  • 08809959694504 ()
  • 08101405701164 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405701096

No Description
New York Optical-International, Inc.
Hazel / -01.25
Not in Commercial Distribution

  • 08809959695464 ()
  • 08101405701096 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700938

No Description
New York Optical-International, Inc.
Green / -01.25
Not in Commercial Distribution

  • 08809959695228 ()
  • 08101405700938 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700860

No Description
New York Optical-International, Inc.
Gray / -01.25
Not in Commercial Distribution

  • 08809959694740 ()
  • 08101405700860 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700792

No Description
New York Optical-International, Inc.
Honey / -01.25
Not in Commercial Distribution

  • 08809959695709 ()
  • 08101405700792 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700624

No Description
New York Optical-International, Inc.
True Sapphire / -01.00
Not in Commercial Distribution

  • 08809959694979 ()
  • 08101405700624 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700556

No Description
New York Optical-International, Inc.
Brown / -01.00
Not in Commercial Distribution

  • 08809959694498 ()
  • 08101405700556 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700488

No Description
New York Optical-International, Inc.
Hazel / -01.00
Not in Commercial Distribution

  • 08809959695457 ()
  • 08101405700488 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700310

No Description
New York Optical-International, Inc.
Green / -01.00
Not in Commercial Distribution

  • 08809959695211 ()
  • 08101405700310 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700242

No Description
New York Optical-International, Inc.
Gray / -01.00
Not in Commercial Distribution

  • 08809959694733 ()
  • 08101405700242 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700174

No Description
New York Optical-International, Inc.
Honey / -01.00
Not in Commercial Distribution

  • 08809959695693 ()
  • 08101405700174 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101405700006

No Description
New York Optical-International, Inc.
True Sapphire / -00.75
Not in Commercial Distribution

  • 08809959694962 ()
  • 08101405700006 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299964

No Description
New York Optical-International, Inc.
Brown / -00.75
Not in Commercial Distribution

  • 08809959694481 ()
  • 08101270299964 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299896

No Description
New York Optical-International, Inc.
Hazel / -00.75
Not in Commercial Distribution

  • 08809959695440 ()
  • 08101270299896 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299728

No Description
New York Optical-International, Inc.
Green / -00.75
Not in Commercial Distribution

  • 08809959695204 ()
  • 08101270299728 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299650

No Description
New York Optical-International, Inc.
Gray / -00.75
Not in Commercial Distribution

  • 08809959694726 ()
  • 08101270299650 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299582

No Description
New York Optical-International, Inc.
Honey / -00.75
Not in Commercial Distribution

  • 08809959695686 ()
  • 08101270299582 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299414

No Description
New York Optical-International, Inc.
True Sapphire / -00.50
Not in Commercial Distribution

  • 08809959694955 ()
  • 08101270299414 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299346

No Description
New York Optical-International, Inc.
Brown / -00.50
Not in Commercial Distribution

  • 08809959694474 ()
  • 08101270299346 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299278

No Description
New York Optical-International, Inc.
Hazel / -00.50
Not in Commercial Distribution

  • 08809959695433 ()
  • 08101270299278 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299100

No Description
New York Optical-International, Inc.
Green / -00.50
Not in Commercial Distribution

  • 08809959695198 ()
  • 08101270299100 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270299032

No Description
New York Optical-International, Inc.
Gray / -00.50
Not in Commercial Distribution

  • 08809959694719 ()
  • 08101270299032 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298974

No Description
New York Optical-International, Inc.
Honey / -00.50
Not in Commercial Distribution

  • 08809959695679 ()
  • 08101270298974 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298806

No Description
New York Optical-International, Inc.
True Sapphire / -00.00
Not in Commercial Distribution

  • 08809959694948 ()
  • 08101270298806 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298738

No Description
New York Optical-International, Inc.
Brown / -00.00
Not in Commercial Distribution

  • 08809959694467 ()
  • 08101270298738 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298660

No Description
New York Optical-International, Inc.
Hazel / -00.00
Not in Commercial Distribution

  • 08809959695426 ()
  • 08101270298660 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298592

No Description
New York Optical-International, Inc.
Green / -00.00
Not in Commercial Distribution

  • 08809959695181 ()
  • 08101270298592 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298424

No Description
New York Optical-International, Inc.
Gray / -00.00
Not in Commercial Distribution

  • 08809959694702 ()
  • 08101270298424 ()


  • Soft corrective contact lens, daily-wear

Comfort Colors - 08101270298356

No Description
New York Optical-International, Inc.
Honey / -00.00
Not in Commercial Distribution

  • 08809959695662 ()
  • 08101270298356 ()


  • Soft corrective contact lens, daily-wear

CAIRE Diagnostics - 00860008017949

Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New Zealand AC Power Cord Cable, Australia/New Zealand - PN 415-0010
Caire Diagnostics Inc.
Fenom Pro, Australia/New Zealand
In Commercial Distribution

  • 00860008017949 ()
900-0012

  • Diagnostic spirometer, professional

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Maxwell® CSC Instrument - 00849811051340

The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS6000
In Commercial Distribution

  • 00849811051340 ()
AS6000

  • Magnetic particle separation instrument IVD

Maxwell® CSC 48 Instrument - 00849811060991

The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS8000
In Commercial Distribution

  • 00849811060991 ()
AS8000

  • Magnetic particle separation instrument IVD

AVEA™ - 10190752175921

AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution

  • 10190752175921 ()
63865

  • Ventilator application software

chemagic 360-D - 06438147356706

The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
Wallac Oy
2024-0010
In Commercial Distribution

  • 06438147356706 ()
2024-0010

  • Magnetic particle separation instrument IVD

chemagic Prepito -D - 06438147332205

The chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
Wallac Oy
2022-0020
In Commercial Distribution

  • 06438147332205 ()
2022-0020

  • Magnetic particle separation instrument IVD

Puritan Bennett - 10884521609181

NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122274
Not in Commercial Distribution

  • 10884521609181 ()


  • Ventilator application software

Puritan Bennett - 10884521808003

NIV plus Software Upgrade Option;For 980 Series Ventilator
Covidien LP
980NIVPLUS
In Commercial Distribution

  • 10884521808003 ()


  • Ventilator application software

Puritan Bennett - 10884521803305

980 Neonatal Expiratory Filtration System, Disposable
Covidien LP
980NEOFLT
In Commercial Distribution

  • 20884521803302 ()
  • 10884521803305 ()


  • Ventilator application software

Puritan Bennett - 10884521808546

High Flow Oxygen Therapy Option Software Upgrade;For 980 Series Ventilator
Covidien LP
980HFO2T
In Commercial Distribution

  • 10884521808546 ()


  • Ventilator application software
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