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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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Planmeca Compact - 06430035420438

Planmeca Compact i is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface which is either a touch panel or a traditional keyboard. The instrument console includes five instrument locations, with easy instrument change.
Planmeca Oy
i
In Commercial Distribution

  • 06430035420438 ()
10031950, 10031951, 10031952, 10031953, 10039745, 10031954, 10031955

  • Dental delivery system

Welch Allyn, Inc. - 00732094067019

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094067019 ()
77791-1MPX

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094066807

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Pl
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066807 ()
77791-MX

  • Aneroid manual sphygmomanometer

Welch Allyn, Inc. - 00732094121315

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121315 ()
77781-MX

  • Aneroid manual sphygmomanometer

xTAG® CYP2C19 Kit v3 - 00840487100172

The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.
Luminex Molecular Diagnostics, Inc
I046B0427
In Commercial Distribution

  • 00840487100172 ()
I046B0427

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

Welch Allyn, Inc. - 00732094201796

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope with LED (#11720-L), MacroView Otoscope with LED (#23810-L), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094201796 ()
77792-ML

  • Noninvasive device battery charger

NATtrol™ - 01220000260252

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ Candida/TV Positive Control
Not in Commercial Distribution

  • 01220000260252 ()
NATCTVPOS-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

Panther Fusion® - 15420045509214

Panther Fusion® Extraction Reagents-S.
Hologic, Inc.
KIT, EXTRACTION REAGENTS - S, FUSION, IVD
In Commercial Distribution

  • 15420045509214 ()
PRD-04331

  • Nucleic acid technique (NAT) kit IVD

Protect-A-Grid - 00860001700183

The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "
Reina Imaging
P[2][X]DR[NG][Y]
In Commercial Distribution

  • 00860001700183 ()
Premium Grid Encasement

  • Stationary x-ray grid

Welch Allyn, Inc. - 00732094066715

Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066715 ()
77792-2MP

  • Aneroid manual sphygmomanometer
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