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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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LANCER/THUNDERBOLT Pedicle Screw System - 00840996173902

T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,24
Choice Spine, LP
M070-LS324
In Commercial Distribution

  • 00840996173902 ()


  • Bone-screw internal spinal fixation system, non-sterile

LANCER/THUNDERBOLT Pedicle Screw System - 00840996173865

T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,24
Choice Spine, LP
M070-LS224
In Commercial Distribution

  • 00840996173865 ()


  • Bone-screw internal spinal fixation system, non-sterile

Band Assemblies - 00190707133443

Elite022 LR6 Double BuccalTube Epic 24
ORTHO ORGANIZERS, INC.
900-12306E-24
In Commercial Distribution

  • 00190707133443 ()


  • Orthodontic metal band

Flex - 00851906007712

Flex Disc 24 count Horizontal Bag
The Flex Company
10150
In Commercial Distribution

  • 20851906007716 ()
  • 00851906007712 ()
  • 30851906007713 ()
  • 00851906007040 ()


  • Menstrual cup/disc, non-latex, single-use

Flex - 00851906007088

Flex 24 count bag (English only)
The Flex Company
Flex 24 count bag (English only)
In Commercial Distribution

  • 10851906007085 ()
  • 00851906007088 ()
  • 00851906007040 ()


  • Menstrual cup/disc, non-latex, single-use

Opti-Handles - 00841962119900

Opti-Handles, 60cm (24") set of 2
Qfix
RT-4457
In Commercial Distribution

  • 00841962119900 ()
RT-4457

  • Indexed-immobilization patient positioning system

Pryor - 00007618875235

4/24/1/2SS, 4 Hook
PRYOR PRODUCTS
107-SST
Not in Commercial Distribution

  • 00007618875235 ()
107-SST

  • Freestanding/bed-attached intravenous pole

Personalized PseudoPatient™ PV - 00860001523218

Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model

Personalized PseudoPatient™ PV - 00860001523201

Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model

Brain Gauge MD - 00860000709408

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
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