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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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This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA AT
In Commercial Distribution

  • 08436046002135 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
The Proteus XR/f AT Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f AT
In Commercial Distribution

  • 08436046002319 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606559 ()
19083/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606542 ()
19083/A

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606535 ()
19077/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606528 ()
19077/A

  • General-purpose surgical spatula
2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
STANDARD TEXTILE CO., INC.
75647454
In Commercial Distribution

  • 00634916788358 ()


  • Surgical gown, reusable
Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals.
Plasmapp Co.,Ltd.
Mini-bio
In Commercial Distribution

  • 08800066500221 ()


  • Biological sterilization indicator reader
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one incubator
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023911 ()
S3080

  • Test tube heater
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