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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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HyProCure Size 10 - M621HYP100

HyProCure Sinus Tarsi Implant Size 10. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HYP-10
In Commercial Distribution

  • M621HYP100 ()

  • 10mm
HYP-10

  • Subtalar implant, non-bioabsorbable

NewLife Intensity 10 - M638AS0994U0

Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options, Re-manufactured.
AIRSEP CORPORATION
AS099-4U
In Commercial Distribution

  • M638AS0994U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS09940

Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options.
AIRSEP CORPORATION
AS099-4
In Commercial Distribution

  • M638AS09940 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS0991U0

Oxygen Concentrator, 1-10 LPM, Dual flow option with standard 1-10 LPM flow meters.
AIRSEP CORPORATION
AS099-1U
In Commercial Distribution

  • M638AS0991U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS099101U0

Oxygen Concentrator, 1-10 LPM, Single flow, with Oxygen Monitor, Re-manufactured.
AIRSEP CORPORATION
AS099-101U
In Commercial Distribution

  • M638AS099101U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS0991010

Oxygen Concentrator, 1-10 LPM Single Flow Meter with Oxygen Monitor option
AIRSEP CORPORATION
AS099-101
In Commercial Distribution

  • M638AS0991010 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS099100U0

Oxygen Concentrator, 1-10 LPM, Single flow, Re-manufactured.
AIRSEP CORPORATION
AS099-100U
In Commercial Distribution

  • M638AS099100U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS0991000

Oxygen Concentrator, 1-10 LPM Single Flow Meter, base model
AIRSEP CORPORATION
AS099-100
In Commercial Distribution

  • M638AS0991000 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS09910

Oxygen Concentrator, 1-10 LPM, Dual flow option, Standard 1-10 LPM flow meters.
AIRSEP CORPORATION
AS099-1
In Commercial Distribution

  • M638AS09910 ()


  • Stationary oxygen concentrator

THC LEVEL 10 - B800THC10UFWDH0

THC LEVEL 10
UTAK LABORATORIES, INC.
THC 10 U F WDH
In Commercial Distribution

  • B800THC10UFWDH5 ()
  • B800THC10UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 10 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
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