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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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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 laboratory drilling system handpiece
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
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 system handpiece, remotely-driven
FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution

  • 00851458005266 ()
DFA2-ASY-0012

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
CORTIGENT, INC.
014103-002
Not in Commercial Distribution

014103

  • Retinal prosthesis system tester/clinical evaluator
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890133
In Commercial Distribution

  • 04251204326175 ()
1890133

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890132
In Commercial Distribution

  • 04251204326168 ()
1890132

  • Microbial identification mass spectrometry system IVD
No Description
Roche Diagnostics GmbH
11776240322
In Commercial Distribution

  • 04015630918409 ()
11776240322

  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
Roche Diagnostics GmbH
3045846122
In Commercial Distribution

  • 04015630918225 ()
3045846122

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
Roche Diagnostics GmbH
7762011190
In Commercial Distribution

  • 04015630946303 ()
7762011190

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
11776223161
In Commercial Distribution

  • 04015630945795 ()
11776223161

  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
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
No Description
Drägerwerk AG & Co. KGaA
8418584
Not in Commercial Distribution

  • 04048675028000 ()


  • Nasal oxygen cannula, CPAP
No Description
Thoratec Corporation
107754OUS
Not in Commercial Distribution

  • 00813024013006 ()
107754OUS

  • Basic power supply, reusable
AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-895
In Commercial Distribution

  • 00810048902354 ()
  • 00810048901166 ()
AS-895

  • Enriched agar culture medium IVD
Contains DIs: E235253A0; E235256A0; E235259A0; E235251A0; E235254A0; E235257A0;E23502530; E23502560; E23502230; E23502280
SHOFU DENTAL CORPORATION
0317B
In Commercial Distribution

  • E2350317B0 ()
0317B

  • Dental abrasive point, reusable
Contains DIs: E23504030; E23504040; E23504010; E23504020; E23502820; E23502850; E23502830; E23502860
SHOFU DENTAL CORPORATION
0308B
In Commercial Distribution

  • E2350308B0 ()
0308B

  • Dental abrasive point, 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, 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, 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, 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, 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
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
No Description
Epocal Inc
HH-1R09-CA-00
In Commercial Distribution

  • 00809708069124 ()
HH-1R09-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
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