SEARCH RESULTS FOR: 2023(1891 results)

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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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MicroAire® - 00847399016973

ORTHOPOWER RECIP. TAPERED BLADE
Microaire Surgical Instruments LLC
277325
Not in Commercial Distribution

  • 00847399016973 ()

  • Width: 11.2 Millimeter
  • Length: 77.7 Millimeter
  • Cutting Thickness: 1 mm


  • Surgical saw blade, reciprocating, single-use

Safety 1st - 00884392951825

5 SECOND RECTAL THERMOMETER
DOREL JUVENILE GROUP, INC.
TH111
In Commercial Distribution

  • 00884392951825 ()


  • Intermittent electronic patient thermometer

NA - 05050474520707

STERILE TRAY RING COVER SPECIFICATIONS
JOHNSON & JOHNSON SURGICAL VISION, INC.
OM271000
Not in Commercial Distribution

  • 15050474520704 ()
  • 05050474520707 ()
OM271000

  • Medical equipment drape, single-use

OpsisDx - B550ENT0100

Metal tray used for quality control of OpsisDx heater
ENTOPSIS, LLC
Quality Control Tray
Not in Commercial Distribution

  • B550ENT0100 ()
ENT010

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

OpsisDx - B550ENT0070

Metal tray used to heat OpsisDx NuTec Slides
ENTOPSIS, LLC
Testing Tray
Not in Commercial Distribution

  • B550ENT0070 ()
ENT007

  • Multiple-type clinical chemistry analyte profile IVD, reagent

OpsisDx - B550ENT0040

Media used for quality control of the OpsisDx platform
ENTOPSIS, LLC
Standard Media
Not in Commercial Distribution

  • B550ENT0040 ()
ENT004

  • Multiple-type clinical chemistry analyte profile IVD, control

OpsisDx - B550ENT0020

Additive used in preparing OpsisDx urine fixative and OpsisDx standard media
ENTOPSIS, LLC
Signal Enhancer
Not in Commercial Distribution

  • B550ENT0020 ()
ENT002

  • Multiple-type clinical chemistry analyte profile IVD, reagent

OpsisDx - B550ENT0010

Four NuTec slides used to create bio-molecular profiles of samples
ENTOPSIS, LLC
NuTec Chamber
Not in Commercial Distribution

  • B550ENT0010 ()
ENT001

  • Multiple-type clinical chemistry analyte profile IVD, reagent

PCRopsis - B5507837810000

PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B5507837810000 ()
783781000

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783781000

PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783780250

PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B55078335000

PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent RVD-E
Not in Commercial Distribution

  • B55078335000 ()
7833500

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B55078331000

PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent RVD-E
Not in Commercial Distribution

  • B55078331000 ()
7833100

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B55078330250

PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent RVD-E
Not in Commercial Distribution

  • B55078330250 ()
7833025

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B55028210000

PCRopsis™ Reagent Buccal (1,000 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent Buccal
Not in Commercial Distribution

  • B55028210000 ()
2821000

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B5502821000

PCRopsis™ Reagent Buccal (100 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent Buccal
Not in Commercial Distribution

  • B5502821000 ()
282100

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B5502820250

PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent Buccal
Not in Commercial Distribution

  • B5502820250 ()
282025

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B5502668503

PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.
ENTOPSIS, LLC
Concentrator
Not in Commercial Distribution

  • B55026685036 ()
  • B5502668503 ()
266850

  • Evaporation/filtration sample concentrator

PCRopsis - B55026682504

PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.
ENTOPSIS, LLC
Concentrator
Not in Commercial Distribution

  • B550266825047 ()
  • B55026682504 ()
2668250

  • Evaporation/filtration sample concentrator

PCRopsis - B5502280010

PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™
ENTOPSIS, LLC
Activator
Not in Commercial Distribution

  • B5502280010 ()
228001

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

PCRopsis - B55022761000

PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022761000 ()
2276100

  • Red blood cell separation reagent

PCRopsis - B55022760100

PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent

VaPro Pocket - 20610075090796

No Touch Urethral Intermittent Catheter, Hydrophilic, Coude Tip, Protective Tip and Sleeve
HOLLISTER INCORPORATED
77164
In Commercial Distribution

  • 20610075090796 ()
  • 00610075090792 ()

  • Length: 16 Inch
  • Catheter Gauge: 16 French


  • Single-administration urethral drainage catheter

VaPro Pocket - 20610075090789

No Touch Urethral Intermittent Catheter, Hydrophilic, Coude Tip, Protective Tip and Sleeve
HOLLISTER INCORPORATED
77144
In Commercial Distribution

  • 20610075090789 ()
  • 00610075090785 ()

  • Catheter Gauge: 14 French
  • Length: 16 Inch


  • Single-administration urethral drainage catheter

freeflex+ - 04250273729931

Reconstitute and/or admix drugs prior to administration to the patient. The device may be used for pediatric and adult populations.
Fresenius Kabi AG
Transfer Adapter
In Commercial Distribution

  • 04250273716818 ()
  • 04250273729931 ()
2870103

  • Fluid transfer set, general-purpose

Halyard - 20680651626725

HYHL600 OS WRAP 54X72
O&M HALYARD, INC.
62672
Not in Commercial Distribution

  • 20680651626725 ()
  • 90680651626724 ()
  • 30680651626722 ()
62672

  • Sterilization packaging, single-use

Halyard - 20680651626541

HYHL600 OS WRAP 54X54
O&M HALYARD, INC.
62654
Not in Commercial Distribution

  • 20680651626541 ()
  • 90680651626540 ()
62654

  • Sterilization packaging, single-use

Halyard - 20680651626480

HYHL600 OS WRAP 48X48
O&M HALYARD, INC.
62648
Not in Commercial Distribution

  • 20680651626480 ()
  • 90680651626489 ()
62648

  • Sterilization packaging, single-use

Halyard - 20680651626459

HYHL600 OS WRAP 45X45
O&M HALYARD, INC.
62645
Not in Commercial Distribution

  • 30680651626456 ()
  • 20680651626459 ()
  • 90680651626458 ()
62645

  • Sterilization packaging, single-use
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