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

  • M638AS099101U0 ()


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

  • M638AS0991010 ()


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

  • M638AS099100U0 ()


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

  • M638AS0991000 ()


  • Stationary oxygen concentrator
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
Guidewire
BOSTON SCIENTIFIC CORPORATION
H749393043000
In Commercial Distribution

  • 08714729886648 ()
  • 08714729887706 ()

  • 0.014 in Diameter
  • 300 cm Effective Length


  • Cardiac/peripheral vascular guidewire, single-use
Guidewire
BOSTON SCIENTIFIC CORPORATION
H749393041900
In Commercial Distribution

  • 08714729886631 ()
  • 08714729887690 ()

  • 0.014 in Diameter
  • 190 cm Effective Length


  • Cardiac/peripheral vascular guidewire, single-use
No Description
SEBIA
4540
In Commercial Distribution

  • 03607360045404 ()
4540

  • Citrate staining/testing reagent IVD
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
Forceps
NOVASTEP
XFP03001
In Commercial Distribution

  • 03700879500614 ()
XFP03001

  • General internal orthopaedic fixation system implantation kit
Drill Guide
NOVASTEP
XDG01001
In Commercial Distribution

  • 03700879500485 ()
XDG01001

  • General internal orthopaedic fixation system implantation kit
No Description
CareDx AB
101.129-06u
In Commercial Distribution

  • 07340035500483 ()


  • HLA class II antigen tissue typing IVD, kit, multiplex
HME
Pharma Systems Ps AB
6063
In Commercial Distribution

  • 30734000671373 ()

  • Length: 7.0 Centimeter
6063

  • Heat/moisture exchanger, single-use
HME
Pharma Systems Ps AB
6060
In Commercial Distribution

  • 30734000671342 ()

  • Length: 7.3 Centimeter
6060

  • Electrocautery system generator, line-powered
CRS Set 10
Candulor AG
662513
In Commercial Distribution

  • E1996625131 ()
662513

  • Dental articulator
10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins
VIASONIX LTD
10 MHz probe
Not in Commercial Distribution

  • 07290016880076 ()


  • General-purpose ultrasound imaging system
10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements.
VIASONIX LTD
10 MHz probe
Not in Commercial Distribution

  • 07290016880410 ()
PVC0332

  • General-purpose ultrasound imaging system
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