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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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PocketPEP Advantage with OxyJET - 10851232007728

A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
D R BURTON HEALTHCARE, LLC
1
In Commercial Distribution

  • 30851232007722 ()
  • 10851232007728 ()
538

  • Incentive spirometer

Cross Bar with Clamp - 10840199536631

Cross Bar with Clamp Assembly
KOROS U.S.A., INC.
8760-20
In Commercial Distribution

  • 00840199536634 ()
  • 10840199536631 ()

  • 9x12mm
8760-20

  • Self-retaining surgical retractor, reusable

HUBBARD TANK WITH SKIMMER - 08436602170162

No Description
ORTOTECSA SL
G.18957-A
In Commercial Distribution

  • 08436602170162 ()


  • Hydrotherapy bath/tank

Genesis MNS with Model-S - M58800101100030

"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system

Wave Electrode with accessories - 08057971592876

Wave Electrode, 60 Hz with accessories - cable length 100 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971592876 ()


  • Myoelectric hand prosthesis

Wave Electrode with accessories - 08057971590971

Wave Electrode, 60 Hz with accessories - cable length 60 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971590971 ()


  • Myoelectric hand prosthesis

Wave Electrode with accessories - 08057971590964

Wave Electrode, 60 Hz with accessories - cable length 30 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971590964 ()


  • Myoelectric hand prosthesis

HANDLE WITH QUICK COUPLING - 03661489086441

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
208644
In Commercial Distribution

  • 03661489086441 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HEXAGONAL SCREWDRIVER WITH UNVERS.JOINT - 03661489069642

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
206964
In Commercial Distribution

  • 03661489069642 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Z-White 98H22 with step - D800ZRAP0951

Z-White 98H22 with step Content: 1 piece Height: 22 mm
ZIRKONZAHN SRL
ZRAP0951
In Commercial Distribution

  • D800ZRAP0951 ()


  • Dental appliance fabrication material, ceramic
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