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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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N/A - 00810050243308

KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052)
DOMICO MED-DEVICE, LLC
5
In Commercial Distribution

  • 00810050243308 ()


  • Multifunction body cushion
  • Radiological general body-part positioner

FST5 - B185FS059370

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system

Dosimetry Check - B229DC051

No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software

LifeStream Application - 00817644020079

No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software

Movement and Compressions System (MAC) - B547RF14210

MAC Strap-XL
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14217 ()
  • B547RF14210 ()
  • B547RF1440219 ()

  • Length: 743 Millimeter
RF1421

  • Intermittent venous compression system

Movement and Compressions System (MAC) - B547RF14200

MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system

Baru - 16975783730028

No Description
Baru Foshan medical technology co., Limited
5
In Commercial Distribution

  • 06975783730021 ()
  • 16975783730028 ()


  • Dental cotton roll

moorFLPI-2 Review PC Software - 15060484490119

moorFLPI-2 Review PC Software V5
MOOR INSTRUMENTS LIMITED
5
In Commercial Distribution

  • 15060484490119 ()


  • Cutaneous microcirculation laser Doppler imaging device

Cytokeratin 5/6 (CK 5/6) - 00847627029096

No Description
BIOCARE MEDICAL LLC
OPAI105T60
In Commercial Distribution

  • 00847627029096 ()


  • Cytokeratin IVD, antibody

Cytokeratin 5/6 (CK 5/6) - 00847627024626

No Description
BIOCARE MEDICAL LLC
AVI105G
In Commercial Distribution

  • 00847627024626 ()


  • Cytokeratin IVD, antibody
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