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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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NA - 03596010463012

DYONICS POWER SAGITTAL SAW MODULE, SERVICE REPLACEMENT
Smith & Nephew, Inc.
7205791S
In Commercial Distribution

  • 03596010463012 ()
7205791S

  • Surgical power tool system handpiece, sawing, line-powered

Conquest Spinal System - 00190837038496

Cervical Drill Smooth Shaft AO Power, 4.0mm
Life Spine, Inc.
2016-0030
In Commercial Distribution

  • 00190837038496 ()
2016-0030

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

Conquest Spinal System - 00190837038489

Cervical Drill Smooth Shaft AO Power, 3.5mm
Life Spine, Inc.
2016-0029
In Commercial Distribution

  • 00190837038489 ()
2016-0029

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

Arx - 00190837036010

ARX T25 POLYAXIAL SCREW DRIVER, NONCANNULATED, POWER
Life Spine, Inc.
175-149
In Commercial Distribution

  • 00190837036010 ()
175-149

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

Arx - 00190837073688

ARX T25 POLYAXIAL SCREW DRIVER, CANNULATED, POWER
Life Spine, Inc.
175-150
In Commercial Distribution

  • 00190837073688 ()
175-150

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

Unitron - 07630034327403

uDirect 3 generic w/ Univ. power supply
Unitron Hearing Ltd
076-5045-T820
In Commercial Distribution

  • 07630034327403 ()
076-5045-T820

  • Spermatozoa/semen analyser IVD, semi-automated

Karman Healthcare - 00810058400017

XO-202 16" Full Power Stand Up Chair
KARMAN HEALTHCARE INC.
XO-202N
In Commercial Distribution

  • 00810058400017 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Karman Healthcare - 00810058400000

XO-202 18" Full Power Stand Up Chair
KARMAN HEALTHCARE INC.
XO-202
In Commercial Distribution

  • 00810058400000 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

CTM Power Chair - 00852202007444

Heavy Duty Rear-Wheels-Operated Power Chair, Red/Blue/Silver
C.T.M. HOMECARE PRODUCT, INC.
HS-5600
Not in Commercial Distribution

  • 00852202007444 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Vilex Power Accessory - 00841731122315

KWire .094 x 9" (2.4x225mm)
VILEX IN TENNESSEE, INC.
K24225-12N
In Commercial Distribution

  • 00841731122315 ()
K24225-12N

  • Orthopaedic bone wire
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