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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No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Roche Diagnostics GmbH
3045838160
In Commercial Distribution

  • 04015630934379 ()
3045838160

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
5917972160
In Commercial Distribution

  • 04015630927906 ()
5917972160

  • Multiple-type clinical chemistry analyte profile IVD, control
Interface Cable of length 150" with a round shape, 12-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684230
In Commercial Distribution

  • 50886333642309 ()
  • 00886333642304 ()

  • cable length 150"
684230

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 8-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684183
In Commercial Distribution

  • 50886333641838 ()
  • 00886333641833 ()

  • cable length 150"
684183

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684147
In Commercial Distribution

  • 50886333641470 ()
  • 00886333641475 ()

  • cable length 150"
684147

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684138
In Commercial Distribution

  • 50886333641388 ()
  • 00886333641383 ()

  • cable length 150"
684138

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684085
In Commercial Distribution

  • 50886333640855 ()
  • 00886333640850 ()

  • cable length 150"
684085

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 8-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684082
In Commercial Distribution

  • 50886333640824 ()
  • 00886333640829 ()

  • cable length 150"
684082

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684078
In Commercial Distribution

  • 50886333640787 ()
  • 00886333640782 ()

  • cable length 150"
684078

  • Electrical-only medical device connection cable, reusable
Interface cable of 150" cable length with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684241
In Commercial Distribution

  • 50886333642415 ()
  • 00886333642410 ()

  • Cable length 150"
684241

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 4-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684188
In Commercial Distribution

  • 50886333641883 ()
  • 00886333641888 ()

  • cable length 150"
684188

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684139
In Commercial Distribution

  • 50886333641395 ()
  • 00886333641390 ()

  • cable length 150"
684139

  • Electrical-only medical device connection cable, reusable
RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10376547
In Commercial Distribution

  • 00630414566771 ()
10376547

  • Calcium (Ca2+) electrode IVD
CA 19-9 Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995492
In Commercial Distribution

  • 00630414598192 ()
10995492

  • Cancer antigen 19-9 (CA19-9) IVD, control
CA 125II - Atellica IM - Master Curve Material Kit 8 x 1 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995484
In Commercial Distribution

  • 00630414598116 ()
10995484

  • Cancer antigen 125 (CA125) IVD, control
CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995488
In Commercial Distribution

  • 00630414598154 ()
10995488

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600284-001
In Commercial Distribution

  • J00716002840011 ()
1600284-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600200-001
In Commercial Distribution

  • J00716002000011 ()
1600200-001

  • Dental power tool handpiece motorless component
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211148 ()


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211117 ()


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
Set of Optima contre angle and licence code for settings
Bien-Air Dental SA
1700733-001
In Commercial Distribution

  • J00717007330011 ()
1700733-001

  • Surgical power tool system control unit, line-powered
Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700569-001
In Commercial Distribution

  • J00717005690011 ()
1700569-001

  • Surgical power tool system control unit, line-powered
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700388-001
In Commercial Distribution

  • J00717003880011 ()
1700388-001

  • Surgical power tool system control unit, line-powered
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601236-001
In Commercial Distribution

  • J00716012360011 ()


  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601164-001
In Commercial Distribution

  • J00716011640011 ()
1601164-001

  • Dental power tool handpiece motorless component
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric micromotor.
Bien-Air Dental SA
1601138-001USA
In Commercial Distribution

  • J0071601138001USA1 ()


  • Dental power tool handpiece motorless component
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed.
Bien-Air Dental SA
1601138-001
In Commercial Distribution

  • J00716011380011 ()
1601138-001

  • Dental power tool handpiece motorless component
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601137-001
In Commercial Distribution

  • J00716011370011 ()
1601137-001

  • Dental power tool handpiece motorless component
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric micromotor.
Bien-Air Dental SA
1601136-001USA
In Commercial Distribution

  • J0071601136001USA1 ()


  • Dental power tool handpiece motorless component
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601136-001
In Commercial Distribution

  • J00716011360011 ()
1601136-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601058-001
In Commercial Distribution

  • J00716010580011 ()
1601058-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601057-001
In Commercial Distribution

  • J00716010570011 ()
1601057-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601055-001
In Commercial Distribution

  • J00716010550011 ()
1601055-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601011-001
In Commercial Distribution

  • J00716010110011 ()
1601011-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600941-001
In Commercial Distribution

  • J00716009410011 ()
1600941-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600939-001
In Commercial Distribution

  • J00716009390011 ()
1600939-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600874-001
In Commercial Distribution

  • J00716008740011 ()
1600874-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600785-001
In Commercial Distribution

  • J00716007850011 ()
1600785-001

  • Dental power tool handpiece motorless component
Bien-Air Dental contra-angles are designed to transmit and apply the mechanical energy produced by an electric micromotor.
Bien-Air Dental SA
1600692-001USA
In Commercial Distribution

  • J0071600692001USA1 ()


  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600692-001
In Commercial Distribution

  • J00716006920011 ()
1600692-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600691-001
In Commercial Distribution

  • J00716006910011 ()
1600691-001

  • Dental power tool handpiece motorless component
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool handpiece motorless component
No Description
ALIMED, INC.
203210
In Commercial Distribution

  • 00733657285789 ()
  • 00733657300253 ()
2970000362

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
91-634
In Commercial Distribution

  • 00733657277432 ()
  • 00733657300031 ()
2970011683

  • Operating table torso positioner
No Description
ALIMED, INC.
71326410
In Commercial Distribution

  • 00733657286632 ()
  • 00733657300529 ()
2970009212

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
71098510
In Commercial Distribution

  • 00733657286069 ()
  • 00733657300291 ()
2970008689

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
203210ML
In Commercial Distribution

  • 00733657285796 ()
  • 00733657300260 ()
2970000363

  • Vulnerable patient home alert system
No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
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