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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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AURA 10 PET-CT - 05430002734026

Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD

Skytron 10" rail - 10841736114893

EQUIPMENT RAIL 10"
SKYTRON LLC
H8-200-02
In Commercial Distribution

  • 10841736114893 ()


  • General utility supply system, ceiling-mounted

KYPHON ACTIVOS 10 - 03760177046528

No Description
TEKNIMED
C10A
In Commercial Distribution

  • 03760177046528 ()
C10A

  • Vertebral bone filler, non-bioabsorbable

KYPHON ACTIVOS 10 - 03760177041677

No Description
TEKNIMED
C10A
Not in Commercial Distribution

  • 03760177041677 ()
C10A

  • Vertebral bone filler, non-bioabsorbable

PREMIO 10 MOXA - 03760262493107

The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
SEDATELEC
PREMIO 10
Not in Commercial Distribution

  • 03760262493107 ()
111237

  • Musculoskeletal infrared phototherapy unit, non-wearable

DESTAINING SOLUTION (10) - 03607360045404

No Description
SEBIA
4540
In Commercial Distribution

  • 03607360045404 ()
4540

  • Citrate staining/testing reagent IVD

Detector UA 10 - 10722355002221

Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Perfectemp®10 - D813SPD13090

PERFECTEMP10 50mL CART BL-2
DEN-MAT HOLDINGS, LLC
SPD1309
In Commercial Distribution

  • D813SPD13090 ()
SPD1309

  • Dental composite resin

Perfectemp®10 - D813SPD13080

PERFECTEMP10 50mL CART B1
DEN-MAT HOLDINGS, LLC
SPD1308
In Commercial Distribution

  • D813SPD13080 ()
SPD1308

  • Dental composite resin

Perfectemp®10 - D813SPD13070

PERFECTEMP10 50mL CART A3.5
DEN-MAT HOLDINGS, LLC
SPD1307
In Commercial Distribution

  • D813SPD13070 ()
SPD1307

  • Dental composite resin
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