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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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Restoration - 06972677871228

No Description
Modern Dental Laboratory (DG) Co., Ltd.
122
In Commercial Distribution

  • 06972677871235 ()
  • 06972677871228 ()


  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay

HPX Gas Handling Manifold - 00850045949037

The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949037 ()
45660

  • Lung MRI xenon hyperpolarization system

Restoration - 08936214220014

Porcelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.
ACESO DENTAL LABORATORY COMPANY LIMITED
001
In Commercial Distribution

  • 08936214220014 ()


  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

WELLlife™ - 00816862026863

WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002-S
In Commercial Distribution

  • 10816862026860 ()
  • 00816862026863 ()
  • 00816862026856 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

CARDINAL HEALTH - 10197106521779

PK ARTERIOGRAM CB
Cardinal Health 200, LLC
SAN4JATCBA
In Commercial Distribution

  • 50197106521777 ()
  • 10197106521779 ()
SAN4JATCBA

  • Cardiac mapping system reference patch

Restoration - 06972677870047

Porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.
Modern Dental Laboratory (DG) Co., Ltd.
004
In Commercial Distribution

  • 06972677870047 ()


  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Flowflex Plus COVID-19 and Flu A/B Home Test - 00810107290002

1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
In Commercial Distribution

  • 30810107290041 ()
  • 00810107290040 ()
  • 00810107290002 ()
  • 30810107290034 ()
  • 00810107290033 ()
  • 60810107290035 ()
  • 40810107290024 ()
  • 00810107290026 ()
  • 10810107290030 ()
  • 50810107290014 ()
  • 40810107290017 ()
  • 00810107290019 ()
  • 10810107290016 ()
  • 20810107290020 ()
  • 10810107290023 ()
  • 20810107290037 ()
  • 60810107290028 ()
  • 60810107290011 ()
  • 40810107290031 ()
  • 30810107290010 ()
  • 50810107290038 ()
  • 30810107290027 ()
  • 20810107290013 ()
  • 70810107290032 ()
  • 80810107290039 ()
  • 50810107290021 ()
  • 80810107290015 ()
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

OSOM Flu SARS-CoV-2 Combo Home - 00742860000089

OSOM Flu SARS-CoV-2 Combo Home
SEKISUI DIAGNOSTICS, LLC
1074
In Commercial Distribution

  • 00742860000089 ()
  • 50742860100654 ()
  • 10742860100656 ()
1074

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Lyher - 06972412619405

The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Restoration - 08936214223169

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
316
In Commercial Distribution

  • 08936214223176 ()
  • 08936214223169 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
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