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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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MADSEN Astera 2 - 05713315007415

1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit
Natus Medical Denmark ApS
8-04-13127
In Commercial Distribution

  • 05713315007415 ()
8-04-13127

  • Speech audiometer

AIMSCREEN MULTIDRUG 2 - 00695684402259

Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine 300 (COC 300) & Marijuana (THC).
GERMAINE LABORATORIES, INC
40225
In Commercial Distribution

  • 00695684402259 ()
  • 00695684402251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

TRAQinform IQ 2 - 00860007104916

No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software

Altair HI 2 - 00860013851521

Fiber Optic Headlight
QED, INC.
QED-7800
In Commercial Distribution

  • 00860013851521 ()


  • Head-worn fibreoptic light

QuickRay HD #2 - 00858475006016

Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
DENTERPRISE INTERNATIONAL, INC.
Hama Size #2
In Commercial Distribution

  • 00858475006016 ()


  • Dental digital imaging sensor, intraoral

Calibration Solution 2 - 05700699441294

S1830 Calibration Solution 2, 200 mL, for ABL800 FLEX
Radiometer Medical ApS
944-129
In Commercial Distribution

  • 05700699441294 ()
944-129

  • Multiple blood gas analyte IVD, calibrator

Calibration Gas 2 - 05700699621757

Calibration gas 2, 10bar on-board gas bottle for USA and Canada
Radiometer Medical ApS
962-175
In Commercial Distribution

  • 05700699621757 ()
962-175

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Calibration Gas 2 - 05700699621702

Calibration gas 2, 10bar on-board gas bottle
Radiometer Medical ApS
962-170
Not in Commercial Distribution

  • 05700699621702 ()
962-170

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Calibration Gas 2 - 05700699621412

Gas cylinder 2.5L Gas 2: 11.22 % CO2, 0 % O2
Radiometer Medical ApS
962-141
Not in Commercial Distribution

  • 05700699621412 ()
962-141

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Calibration Gas 2 - 05700699620965

Calibration Gas 2 standard 1 Litre, 10% CO2, balance: N2
Radiometer Medical ApS
962-096
Not in Commercial Distribution

  • 05700699620965 ()
962-096

  • Calibration gas/non-refillable cylinder
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