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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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Batrik PrAmLi Power Enzyme - 00690521016675

PrAmLi Power3 Enzymes, Mild Foam Detergent, 3.8 L
Batrik Medical Manufacturing Inc
SS-21-2001
In Commercial Distribution

  • 00690521016675 ()
SS-21-2001

  • Medical device disinfection agent

Batrik PrAmLi Power Enzyme - 00690521016644

PrAmLi Power3 Enzymes, Low Foam Detergent, 3.8 L
Batrik Medical Manufacturing Inc
SS-21-1001
In Commercial Distribution

  • 00690521016644 ()
SS-21-1001

  • Medical device disinfection agent

Batrik PrAmLi Power Enzyme - 00690521015869

"PrAmLi Power3 Enzymes, Ready to Use Foaming Spray, 12 x 946 mL (12 x 32 oz)"
Batrik Medical Manufacturing Inc
SS-21-4012
In Commercial Distribution

  • 00690521015869 ()
SS-21-4012

  • Medical device disinfection agent

INFINITY M500 WITH POWER - 04049098054447

No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS20407
In Commercial Distribution

  • 04049098054447 ()


  • General-purpose multi-parameter bedside monitor

DynaFlex Power Chain Short - D8411235XX1

No Description
Ortho Solutions, LC
1
In Commercial Distribution

  • D8411235XX1 ()


  • Orthodontic inter-bracket elastic chain

DynaFlex Power Chain Long - D8411234XX1

No Description
Ortho Solutions, LC
1
In Commercial Distribution

  • D8411234XX1 ()


  • Orthodontic inter-bracket elastic chain

DynaFlex Power Chain Continuous - D8411233XX1

No Description
Ortho Solutions, LC
1
In Commercial Distribution

  • D8411233XX1 ()


  • Orthodontic inter-bracket elastic chain

REFRACTIVE POWER / CORNEAL ANALYZER - 04987669100776

The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses.
NIDEK CO.,LTD.
OPD-Scan III
In Commercial Distribution

  • 04987669100776 ()


  • Corneal topography system
  • Keratoscope, powered
  • Automated ophthalmic refractometer

Baha 5 Power, Blonde - 09321502034586

No Description
Cochlear Bone Anchored Solutions AB
95470
In Commercial Distribution

  • 09321502034586 ()
95470

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Power, Copper - 09321502034623

No Description
Cochlear Bone Anchored Solutions AB
95474
In Commercial Distribution

  • 09321502034623 ()
95474

  • Bone-conduction hearing implant system sound processor/vibrator
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